BIOCOTRON-D- dextromethorphan hbr, guaifenesin, phenylephrine hcl suspension/ drops

Biocotron-D by

Drug Labeling and Warnings

Biocotron-D 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 5mL)                   Purpose

Dextromethorphan HBr, 10 mg ................................. Cough Suppressant

Guaifenesin, 200 mg ................................................ Expectorant

Phenylephrine HCl, 5 mg ...................................... Nasal Decongestant

PURPOSE

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold. 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, trouble urinating due to an enlarged prostate gland, cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask doctor or pharmacist before use if you are taking any other nasal decongestant or stimulant.

When using this product do not use more than directed.

PREGNANCY OR BREAST FEEDING

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

DO NOT USE

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 a doctor or pharmacist before taking this product.

Stop use and ask a doctor before use if:

• you get nervous, dizzy or sleepless; symptoms do not get better within 7 or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
  

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions: Do not take more than 3 doses in any 24-hour period.

• Age: Dose
• Adults and children 12 years of age and over: 2 teaspoons every 4 hours
• Children 6 to under 12 years of age: 1 teaspoon every 4 hours
• Children 2 to under 6 years of age: 1/2 teaspoon every 4 hours
• Children under 2 years of age: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients: Carboxymethyl cellulose sodium, Cellulose, Citric Acid, Flavor, Propylene Glycol, Sodium Benzoate, Sodium Saccharin, Water

QUESTIONS

Questions or comments? 1-305-403-3788

INDICATIONS & USAGE

Other information:Store at room temperature 15-30 degrees C (59-86 degrees F)

Tamper evident:Do not use if seal under cap (or cello-band over cap) is torn, broken or missing.

Each teaspoonful (5mL) contains:Sodium 6 mg

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOCOTRON-D 
dextromethorphan hbr, guaifenesin, phenylephrine hcl suspension/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-208
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)

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: 45737-208-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2013

Labeler - Advanced Generic Corporation (831762971)