Label: BIOSPEC DMX- dextromethorphan, guaifenesin liquid
- NDC Code(s): 45737-211-16
- Packager: Advanced Generic Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated December 23, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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WARNINGS
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.
- 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.
- DO NOT USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIOSPEC DMX
dextromethorphan, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-211 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 25 mg in 5 mL Inactive Ingredients Ingredient Name Strength Menthol (UNII: L7T10EIP3A) Water (UNII: 059QF0KO0R) POTASSIUM GUAIACOLSULFONATE (UNII: TTK33Z47F1) Glycerin (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) Sodium Citrate (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color Score Shape Size Flavor CHERRY (Cherry Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45737-211-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2009 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)
