Biocotron

Active Ingredients: (in each 5 mL tsp.)              Purpose

Dextromethorphan Hydrobromide 10 mg.................. Cough Suppressant

Guaifenesin 100 mg .............................................. Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritations as may occur with a cold

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

When using this product, do not exceed recommended dosage

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

Do not Use

If you are now taking a prescription monoamine oxidase inhibitor (MAOI)
(certain drugs for depression, psychiatric or emotional conditions or
Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you
do not know if you are taking a prescription drug that contains an MAOI;
ask your doctor or pharmacist before taking this product.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Directions Do not take more than 6 doses in any 24-hour period, unless directed by a physician

adults and children 12 years and over, 2 teaspoonfuls every 4 hours

children 6 years to under 12 years, 1 teaspoonful every 4 hours

children under 6 years, ask a doctor

Other information store at controlled room temperature
20-25 C (68-77 F); excursion permitted to 15-30 C (59-86 F). Tamper
evident by imprinted heat seal under cap. Do not use if there is
evidence of tampering.
Warning: Phenylketonuric: Contains 11.25 mg of phenylalanine per 5 ml (one teaspoonful) dose.

Inactive ingredients Aspartame, citric acid, flavor, glycerine,
hydroxyethylcellulose, methylparaben, propylene glycol, purified
water and sodium citrate.

Questions or comments? 1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, FL 33166.
www.advancedgeneric.com

Biocotron  - dextromethorphan, guaifenesin liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:45737-209(NDC:65852) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 10 mg  in 5 mL Guaifenesin (Guaifenesin) Guaifenesin 100 mg  in 5 mL

Product Characteristics Color      Score      Shape Size Flavor CHERRY (Cherry Flavor) Imprint Code Contains

Packaging # Item Code Package Description 1 NDC:45737-209-16 473 mL in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2009

Labeler - Advanced Generic Corporation (831762971)

Revised: 11/2010   Advanced Generic Corporation

Applies to dextromethorphan / guaifenesin: oral capsule, oral liquid, oral packet, oral solution, oral syrup, oral tablet, oral tablet extended release 12 hour

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to dextromethorphan / guaifenesin: oral capsule, oral capsule extended release, oral elixir, oral granule, oral liquid, oral suspension extended release, oral tablet, oral tablet extended release

Nervous system

Nervous system side effects of dextromethorphan have included drowsiness and dizziness. Adverse effects, which have occurred at higher doses, include excitation, mental confusion, and opioid like respiratory depression. In some cases of abuse, patients have experienced euphoria, hyperactivity, mania, and auditory and visual hallucinations.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting and constipation.[Ref]

Dermatologic

Dermatologic side effects have included pruritus and rash.[Ref]

Hypersensitivity

Hypersensitivity side effects of dextromethorphan have included fixed-drug eruptions.[Ref]

Some side effects of Biocotron may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.