BIOCOTRON PED- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Biocotron by

Drug Labeling and Warnings

Biocotron 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, 15 mg ................................. Cough Suppressant

Guaifenesin, 350 mg ................................................ Expectorant

Phenylephrine HCl, 10 mg ...................................... Nasal Decongestant

PURPOSE

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

INDICATIONS & USAGE

Uses

• non-narcotic cough suppressant which temporarily calms cough due to minor throat and bronchial irritation as may occur with the common cold
• calms the cough control center and relieves coughing
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive.
• temporarily relieves nasal congestion due to the common cold
• helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure

WARNINGS

Warnings:

Do no exceed recommended dosage

a persistent cough may be a sign of a serious condition. If cough persist for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache, constult a doctor

Do not use this product if you

are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional condition. or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or phamacist before taking thie product.

Ask doctor or pharmacist before use if you have

• a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
• high blood pressure
• heart disease
• thyroid disease
• diabetes
• difficulty in urincation due to enlargment of the prostate gland

Stop use and ask a doctor if:

• nervousness, dizziness, or sleeplessness occur.
• if symptoms do not improve within 7 days or are accompanied by fever

Ask a doctor before use if you are taking sedatives or tranquilizers.

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.

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

Directions: Take very 4 hours, not to exceed 6 doses in 24 hours or as directed by physician

• Age: Dose
• Adults and children 12 years of age or older: 1 teaspoonful (5 mL) every 4 hours
• Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 4 hours
• Children under 6 years of age: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients: citric acid, eucalyptus oil, glycerin, hydroxyethyl cellulose, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.

QUESTIONS

Questions or comments? 1-305-403-3788

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOCOTRON  PED
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-261
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	350 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45737-261-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2015

Labeler - Advanced Generic Corporation (831762971)