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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients (in each 5mL)                   Purpose

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

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

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



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:

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.


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


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

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 age1/2 teaspoon every 4 hours
Children under 2 years of ageAsk a doctor

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

Questions or comments? 1-305-403-3788

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

biocotron

BIOCOTRON-D 
dextromethorphan hbr, guaifenesin, phenylephrine hcl suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-208
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRY (Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-208-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2013
Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2020
Document Id: 09f2b66a-cbe2-4baf-a9a6-a55f0426cdd7
Set id: d1da2b49-af3a-4b80-a62c-c9147dab3113
Version: 4
Effective Time: 20201223
 
Advanced Generic Corporation