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Acetaminophen belongs to a class of drugs called analgesics (pain relievers) and antipyretics (fever reducers). The exact mechanism of action of acetaminophen is not known. Acetaminophen relieves pain by elevating the pain threshold, that is, by requiring a greater amount of pain to develop before it is felt by a person. It reduces fever through its action on the heat-regulating center of the brain. Specifically, it tells the center to lower the body's temperature when the temperature is elevated. Acetaminophen was approved by the FDA in 1951.



Acetaminophen is metabolized (eliminated by conversion to other chemicals) by the liver. The potential for acetaminophen to harm the liver is increased when it is combined with alcohol or drugs that also harm the liver.



When used appropriately, side effects are rare. The most serious side effect is liver damage due to large doses, chronic use or concomitant use with alcohol or other drugs that also damage the liver.



Source: www.medicinenet.com

The ingredients in a product that are specifically designed to achieve the product performance objectives.

For example, an antacids active ingredient is calcium carbonate. Antacids may also contain: corn starch, talc, artificial colors etc...that do not help with acid reduction.

Benzyl alcohol, also called phenylmethanol, is a clear, colorless liquid with a mild pleasant aromatic odor. It is a primary alcohol having very reactive methylene and nuclear hydrogen groups, melting at 15 C and Boiling at 205 C. It is soluble in water and readily soluble in alcohol and ether. Benzyl alcohol is prepared by the hydrolysis of benzyl chloride in the presence of soda ash. It reacts with acids ( acetic, benzoic, and sebacic acids) to form esters and other compounds. and thus is used frequently as a valued intermediate in the soap, perfume, and flavor industries. Benzyl alcohol has properties of strong polarity and limited water solubility and thus is used as a general solvent for inks and lacquers and a degreasing agent in cleaners. This compound is used as a photographic developer in the processing of color movie films and as a dyeing assistant for filament nylons. Its applications include many pharmaceutical preparations as a bacteriostatic. It was used for antipruritic activity to relieve itching.

It is the ester of butyl alcohol and p-hydroxybenzoic acid and is classed as esters and phenols. It can be used as a fragrance ingredient, as well as a preservative.

Castor Oil has been used therapeutically in ancient India, China, Persia, Egypt, Africa, Greece, Rome, the Americas, and in 17th century Europe. This oil is also known as Palma Christi or the "Palm of Christ". Edgar Cayce mentions castor oil many, many times in his readings.

Today it is used as an emollient and skin softener, treatment of gastrointestinal problems, lacerations, and other skin disorders such as psoriasis. Also used to boost your immune system. It is also found in many skin care products.

Cellulose may be used in foods as a hydrocolloid. As a vegetable gum, it serves a major role as a stabilizer. Cellulose is also frequently used as a fat replacer or substitute. In foods, the cellulose ingredients are insoluble fibrous particles that are capable of holding water and suspending the dispersed particulates. It can replace fat because it gives an appropriate mouth feel and lends a glossy opaque appearance when used.

Cellulose is an excellent source of insoluble fiber. Unlike soluble fiber, insoluble fiber does not feed bacteria well and is not readily fermented into short chain fatty acids.

Cornstarch, or cornflour, is the starch of the maize grain, commonly known as corn. It is also ground from the endosperm, or white heart, of the corn kernel. It has a distinctive appearance and feel when mixed raw with water or milk, giving easily to gentle pressure but resisting sudden pressure. It is usually included as an anti-caking agent in powdered sugar (10X or confectioner's sugar). For this reason, recipes calling for powdered sugar often call for at least light cooking to remove the raw cornstarch taste.



Cornstarch is often used as a binder in puddings and similar foods. Most of the packaged pudding mixes available in grocery stores include cornstarch. Cornstarch puddings may be easily made at home, benefiting from the use of a double boiler. The most basic such pudding may be made only from milk, sugar, cornstarch and a flavoring agent.



It is also used as a thickener in many recipes. Cornstarch is best dissolved in cold water, as it forms obstinate lumps when mixed with warm or hot water.



Cornstarch also has many uses in the manufacturing of environmentally-friendly products. For example, in 2004, the Japanese company Pioneer announced a biodegradable Blu-Ray disc made out of cornstarch.



Cornstarch has been used as a replacement for talcum powder by some.



Due to cross contamination, wheat may be present. Read food label carefully to ensure it is Gluten Free.

Corn starch does not trigger the autoimmune response in celiac disease. It contains a form of gluten (a type of combined grain protein), but not the same form as wheat, barley, rye, kamut, spelt, and triticale. ??If the corn starch is not contaminated, it is safe for celiacs



Source:http://en.wikipedia.org/wiki/Cornstarch

D&C Yellow No. 10 is manufactured by condensing quinaldine with phthalic anhydride to give the unsulfonated dye, which is then sulfonated with oleum.

The color additive D&C Yellow No. 10 may

be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice. Allowed in Drugs and Cosmetics only. Banned in Foods.



source: http://vm.cfsan.fda.gov

EDTA is a widely used acronym for the chemical compound ethylenediaminetetraacetic acid (which has many other names, see Table). EDTA is a polyamino carboxylic acid with the formula [CH2N(CH2CO2H)2]2. This colourless, water-soluble solid is widely used to dissolve scale. Its usefulness arises because of its role as a chelating agent, i.e. its ability to "sequester" metal ions such as Ca2+ and Fe3+. After being bound by EDTA, metal ions remain in solution but exhibit diminished reactivity. EDTA is produced as several salts, notably disodium EDTA and calcium disodium EDTA.



In industry, EDTA is mainly used to sequester metal ions in aqueous solution. In the textile industry, it prevents metal ion impurities from modifying colours of dyed products. In the pulp and paper industry, EDTA inhibits the ability of metal ions, especially Mn2+, from catalyzing the disproportionation of hydrogen peroxide, which is used in "chlorine-free bleaching." Similarly, EDTA is added to some food as a preservative or stabilizer to prevent catalytic oxidative decolouration which is catalyzed by metal ions.[8] In personal care products, it is added to cosmetics to improve their stability toward air.[9] In Soft drinks containing ascorbic acid and sodium benzoate, EDTA mitigates formation of benzene (a carcinogen).[10]



The reduction of water hardness in laundry applications and the dissolution of scale in boilers both rely on EDTA and related complexants to bind Ca2+ and Mg2+ ions as well as other metal ions. Once bound to EDTA, these metal centers tend not to form precipitates or to interfere with the action of the detergents. For similar reasons, cleaning solutions often contain EDTA.



The solubilization of ferric ions near neutral pH is accomplished using EDTA. This property is useful in agriculture including hydroponics, especially in calcareous soils. Otherwise, at near neutral pH, iron(III) forms insoluble salts, which are less bioavailable. Aqueous [Fe(edta)]- is used for removing ("scrubbing") hydrogen sulfide from gas streams. This conversion is achieved by oxidizing the hydrogen sulfur to elemental sulfur, which is non-volatile:



2 [Fe(edta)]- + H2S ? 2 [Fe(edta)]2- + S + 2 H+

In this application the ferric center is reduced to its ferrous derivative, which can then be reoxidized by air. Similarly, nitrogen oxides are removed from gas streams using [Fe(edta)]2-. The oxidizing properties of [Fe(edta)]- are also exploited in photography where it is used to solubilize silver particles.[4]



EDTA was an most important chelating agents used in the separation of the lanthanide metals by ion-exchange chromatography. Perfected by F.H. Spedding et al. in 1954, the method relies on the steady increase in stability constant of the lanthanide EDTA complexes with atomic number. Using sulfonated polystyrene beads and copper(II) as a retaining ion, EDTA causes the lanthanides to migrate down the column of resin while separating into bands of pure lanthanide. The lanthanides elute in order of decreasing atomic number. Due to the expense of this method, relative to counter-current solvent extraction, ion-exchange is now used only to obtain the highest purities of lanthanide (typically greater than 4N, 99.99%).[

Blue 1

Commonly known as Brilliant Blue FCF or E133, Blue 1 is found in beverages, dairy products, jellies, etc. as a food coloring. It can produce various shades of green according to the manufacture’s wishes in conjunction with Yellow 5. It was originally derived from coal tar, but now made from an oil base such as petroleum. All dyes are considered additives by the FDA through the Federal Food, Drug, and Cosmetic Act (FD&C Act) since it is not used for the purpose of consumption, but to improve the appearance of the product. The synthetic dye does not fade as easily as other natural sources of blue dye such as indigo and is more preferred by the manufacturer. The consumption of artificial dyes has been thought to increase hyperactivity in children. It has been banned in much of Europe, but is still considered legal according to the European Union and the United States.

"CSPI Urges FDA to Ban Artificial Food Dyes Linked to Behavior Problems ~ Newsroom ~ News from CSPI ~ Center for Science in the Public Interest." Center for Science in the Public Interest. Web. 16 May 2011. .

"Electronic Code of Federal Regulations." GPO Home Page. Title 21. Part 74, 12 May 2011. Web. 16 May 2011. .

"FD&C Blue No.1,Brilliant Blue FCF,FD&C Blue No.1 Dye,FD&C Blue No.1 Color." Food Additives, Natural Food Additives, Food Colors, Natural Food Colors. Web. 16 May 2011. .

"Where does blue food dye come from?: Scientific American." Science News, Articles and Information | Scientific American. Web. 18

May 2011. .

FD&C Blue No.2, commonly added to tablets and capsules; also used in ice cream, sweets, baked goods, confectionary, biscuits, synthetic coal tar derivative; may cause nausea, vomiting, high blood pressure, skin rashes, breathing problems and other allergic reactions. Banned in Norway. The largest study suggested, but did not prove, that this dye caused brain tumors in male mice. The FDA concluded that there is "reasonable certainty of no harm."



Ref: Food additives guide

(http://www.foodag.com/en/100.htm)

Ref: Center for science in the public interest (http://www.cspinet.org/reports/chemcuisine.htm#Alphabetical)

Gelatin

Gelatin is derived from collagen, which is mainly involved with connective tissues and bones. It is known for its capability to gel and form semi-solids with its solution. The type of gelatin depends on the source of where it came from. Many of these sources include cattle bones, cattle hides, pork skins, and dried crushed bone. Cattle hides are the least used source for gelatin, while crushed bone is used mostly for photographic or pharmaceutical applications. Pork skin is the most commonly used raw source for edible gelatin in North America. The gelatin produced, Type A gelatin is extracted from the pork skin through a complex process involving acid treatment, washing, sterilization, and more. Because of the use of animal as a raw material source, gelatin should be restricted from diets concerning animal by-products.

"How We Make Gelatin." Gelatin Information, News, History and More. Gelatin Manufacturers Institute of America, 2001. Web. 17 May 2011.

.

Red 40

Red 40 is a dye commonly used as food coloring in today’s foods. The proper chemical name is actually

6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid, but also

known as “azo” dye. By itself Red 40 has an orangish-red color and found in cherry and strawberry flavored foods. Orange foods are typically dyed with Yellow 6. See Yellow 6. All dyes are considered additives by the FDA through the Federal Food, Drug, and Cosmetic Act (FD&C Act) since it is not used for the purpose of consumption, but to improve the appearance of the product. For example, chocolate pudding would be slightly greener without the use of red dye. Not just limited to foods, Red 40 is also used for coloring in cosmetics and sold as powders or liquids.

"Electronic Code of Federal Regulations." GPO Home Page. Title 21. Part 74, 12 May 2011. Web. 16 May 2011. .

FD&C Red Dye #40 Information, Education and Discussion. Web. 16 May 2011. .

Calcium (or Sodium) propionate prevents mold growth on bread and rolls. The calcium is a beneficial mineral; the propionate is safe. Sodium propionate is used in pies and cakes, because calcium alters the action of chemical leavening agents.

White in colour, Titanium dioxide is extracted from the naturally occurring mineral Ilmenite, (named after the Ilmen Mountains in Russia), an iron-black, heavy, metallic oxide mineral, composed of iron and titanium oxide.



Thought not to be easily absorbed, although detectable amounts can be found in the blood, brain and glands with the highest concentrations being in the lymph nodes and lungs, it is excreted from the body with urine.



Can be found in tablets and capsules, cottage and Mozzarella cheeses, horseradish cream and sauces, lemon curd, toothpaste, and white paint, also in sweets where it is often used to provide a barrier between different colours. Used to increase opacity in some sauces.



Banned in Germany.

No adverse effects are known.

Pollutes waterways.

This inexpensive detergent is commonly used in cosmetic cleansers, hair shampoos, bath and shower gels, bubble baths, etc. - It is probably the most dangerous ingredient used in skin and hair-care products. In the cleaning industry SLS is used in garage floor cleaners, engine degreasers, car-wash soaps, etc. It is very corrosive and readily attacks greasy surfaces.



Sodium lauryl sulfate is used throughout the world for clinical testing as a primary skin irritant. Laboratories use it to irritate skin on test animals and humans so that they may then test healing agents to see how effective they are on the irritated skin.



A recent study at the University of Georgia Medical College, indicated that SLS penetrated Into the eyes as well as brain, heart, liver, etc., and showed long-term retention in the tissues. The study also indicated that SLS penetrated young children's eyes from developing properly and caused cataracts to develop In adults.

used as a confectionery mold release agent.

contained in many Nutritional Supplements

for its supply of magnesium.

Hypromellose is used to treat conditions where not enough tears are produced to keep the eye lubricated and clean. Hypromellose lubricates the surface of the eye in the same way as natural tears. It can therefore be used to relieve the dryness and pain associated with reduced or abnormal tear production

Propyl paraben is a preservative that is derived from PABA and is extensively used in cosmetics, and helps to prevent the formation of yeast and mould in products.

The parabens are esters of para-hydroxibenzoic acid. The two most common esters are methyl and propyl parabens, which are approved for food use in the United States under the GRAS classification. The maximum concentration allowed is 0.1 %. They are most active against yeasts and molds.



Parabens are white powders with faint odor and fair solubility in water at room temperature. The solubility is greatly increased by heating the water to 160°F-180°F. Methyl paraben is more soluble in water but less effective against molds than propyl paraben. To balance these differences, mixtures of 2 to 3 parts of methyl paraben with 1 part propyl paraben are normally used.



Important advantages of parabens are their effectiveness at higher pH values, from 3 up to 8, and stability to high and low temperatures, even to steam sterilization. Despite these properties, parabens are not as widely used as other antimicrobial agents, probably due to higher cost and flavor objections. Applications include bakery products (formulated without yeast), beverages, flavor extracts, food colors, fruit products, jams, jellies, preserves (artificially sweetened), gelatin, marinated and smoked fish, pickles, salad dressings, syrups, wine and olives.



If preservatives are used in a food, they must be declared in the list of ingredients, along with a short explanation of intended use, such as "preservative", "mold inhibitor", "to retard spoilage".

APPLICATIONS :

Sodium starch glycolate is widely used in oral pharmaceuticals as a disintegrant in capsule and tablet formulations. It is recommended to use in tablets prepared by either direct-compression or wet-granulation processes.



The recommended concentration in a formulation is 2-8%, with the optimum concentration about 4% although in many cases 2% is sufficient. Disintegration occurs by rapid uptake of water followed by rapid and enormous swelling.



The disintegrant efficiency of sodium starch glycolate is unimpaired in the presence of hydrophobic excipients, such as lubricants unlike many other disintegrants.



Increasing the tablet compression pressure also appears to have no effect on disintegration time.



Sodium starch glycolate has also been investigated for use as a suspending vehicle.



STABILITY AND STORAGE CONDITIONS :

Tablets prepared with sodium starch glycolate have good storage properties. Sodium starch glycolate is stable and should be stored in a well-closed container to protect it from wide variations in humidity and temperature that may cause caking. The physical properties of sodium starch glycolate remain unchanged for up to 4 years if stored at moderate temperatures and humidity.

Inactive ingredients are also called excipients -- these are ingredients that are found in the dosage form being consumed that are not considered active ingredients