BIOCOF- dextromethorphan hydrobromide, guaifenesin, phenylephrine hcl liquid

Biocof by

Drug Labeling and Warnings

Biocof by is a Otc medication manufactured, distributed, or labeled by Advanced Generic Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each 5 mL tps.)        Purpose

Dextromethorphan Hydrobromide.... 20 mg...........................Cough suppressant

Guaifenesin.... 400 mg........................................................Expectorant

Phenylephrine HCL.....10 mg...............................................Nasal Decogestant

PURPOSE

Uses:

• temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants.
• Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to the common cold

WARNINGS

Warnings:

Ask a doctor before use if you have:

• Heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to an enlarged prostate gland
• a cough with too much phlegm (mucus)
• a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Ask a  doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargment or prostate gland
• a cough with too much phlegm (mucus)
• a persistent or chronic cough as occurs with smoking asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before useif you are taking any other nasal decongestant or stimulant.

When using this product do not use more than directed.

Stop use and ask a doctor if: you get nervous, dizzy, or sleepless; symptoms do not get better within 7 days, or are accompanied by fever

• cough lasts more than 7 days, comes back, or is accompanied by a fever, rash or persistent headache. These could be signs of serious condition.

DO NOT USE

Do not use:

If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs of 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 MAOI; ask your doctor or pharmacist before taking this product.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

Directions Do not exceed more than 6 doses in any 24 hours period.

• Adults and children 12 years of age and over.: Take 1 teaspoonful (5 mL) every 4 hours
• Children under 12 years of age.: Consult a physician

INDICATIONS & USAGE

Uses

• temporary relives cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
• helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to the common cold

INACTIVE INGREDIENT

Inactive Ingredients: Cherry flavor, Citric Acid, Glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucralose

QUESTIONS

Questions or comments? 1-305-403-3788

Manufactured for: Advanced Generic Corporation
                          Miami, FL 33166

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOCOF 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-249
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45737-249-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/2012

Labeler - Advanced Generic Corporation (831762971)