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Biocotron

Generic Name: dextromethorphan, guaifenesin
Dosage Form: oral liquid

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.

Drug Facts

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



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