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Biospec

Advanced Generic Corporation

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients: (in each 5 mL tsp.)              Purpose

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

Guaifenesin 25 mg .............................................. Expectorant

Purpose

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




Uses

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

Biospec

Biospec

Dextromethorphan, Guaifenesin LIQUID

Product Information

Product Type Human otc drug label 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 15 mg
Guaifenesin GUAIFENESIN 25 mg

Inactive Ingredients

Ingredient Name Strength
MENTHOL
water
POTASSIUM GUAIACOLSULFONATE
GLYCERIN
SODIUM BENZOATE
SODIUM CITRATE
saccharin sodium

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:45737-211-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-10-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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