Label: BRONCOTRON- dextromethorphan, guaifenesin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 11026-2640-4 - Packager: Seyer Pharmatec, Inc.
- 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 28, 2011
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ACTIVE INGREDIENT
Active ingredients(in each 5 mL teaspoonful) .......................................... Purpose
Dextromethorphan HBR, 10 mg..................................................................Cough suppressant
Guaifenesin, 100 mg................................................................................. Expectorant - PURPOSE
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WARNINGS
Warnings:
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, bronchitis, or emphysema.
- 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.
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DO NOT USE
Do not use if you are now taking a prescription monoamine oxidase (MOAI) (certain drugs for depression, pychiatric, or emotional conditions, or Parkison's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
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INGREDIENTS AND APPEARANCE
BRONCOTRON
dextromethorphan, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11026-2640 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 ASPARTAME (UNII: Z0H242BBR1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POLYGLYCERIN-10 (UNII: P9060O936A) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) 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:11026-2640-4 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/1998 Labeler - Seyer Pharmatec, Inc. (832947126) Registrant - Seyer Pharmatec, Inc. (832947126)