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Name:Biospecdmx
Manufacturer:Advanced Generic Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BIOSPEC DMX - dextromethorphan hydrobromide and guaifenesin liquid 
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 5 mL tsp.)              Purpose

Dextromethorphan Hydrobromide 15 mg.................. Cough Suppressant

Guaifenesin 25 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

Warnings
  • Do not exceed recommended dosage.
  • 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.
Ask a doctor before use if you have
  • Cough that occurs with too much phlegm (mucus)
  • Cough that lasts or is such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or 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.

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, 1 teaspoonfuls (5 ml) every 4 hours

children 6 years to under 12 years, 1/2 teaspoonful (2.5 ml) every 4 hours

children 4 to 6 years, 1/4 teaspoonful (1.25 ml) every 4 hours

children under 4 years of age, consult a doctor

Other information store at room temperature 15-30 C (59-86 F).

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

Inactive ingredients Cherry Flavor, Glycerin, Menthol, Potassium Guaiacol Sulfonate,
Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Water.

Questions or comments? 1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, FL 33166.
www.advancedgeneric.com

BiospecDMXLabel


BIOSPEC  DMX
dextromethorphan, guaifenesin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-211(NDC:65852-030)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 15 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin 25 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Menthol  
Water  
POTASSIUM GUAIACOLSULFONATE  
Glycerin  
SODIUM BENZOATE  
Sodium Citrate  
SACCHARIN SODIUM  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (Cherry Flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45737-211-16 473 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 10/01/2009

Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2010 Advanced Generic Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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