Label: BREACOLD ADULT- guaifenesin, dextromethorphan hbr liquid
- NDC Code(s): 53145-040-04
- Packager: Menper Distributors, 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.
Updated February 18, 2022
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- Active ingredients (in each 10mL tsp)
- Do not exceed recommended dosage.
Do not use:
- this product for persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
- 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- KEEP OUT OF REACH OF CHILDREN
- If pregnant or breast-feeding
- Directions: Do not exceed 6 doses in 24 hours.
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
guaifenesin, dextromethorphan hbr liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53145-040 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 10 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID ACETATE (UNII: DSO12WL7AU) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) D&C RED NO. 33 (UNII: 9DBA0SBB0L) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) RASPBERRY (UNII: 4N14V5R27W) Product Characteristics Color red Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53145-040-04 1 in 1 CARTON 02/21/2012 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/21/2012 Labeler - Menper Distributors, Inc. (101947166)