Label: BIOCOTRON- dextromethorphan, guaifenesin liquid
- NDC Code(s): 45737-209-16
- 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.
Updated December 23, 2020
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- ACTIVE INGREDIENT
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.
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
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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
dextromethorphan, guaifenesin liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-209 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg in 5 mL Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength Citric Acid Monohydrate (UNII: 2968PHW8QP) Water (UNII: 059QF0KO0R) Methylparaben (UNII: A2I8C7HI9T) Propylene Glycol (UNII: 6DC9Q167V3) Sodium Citrate (UNII: 1Q73Q2JULR) PROPYLPARABEN (UNII: Z8IX2SC1OH) SUCRALOSE (UNII: 96K6UQ3ZD4) 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:45737-209-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2009 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)