Label: DEXTROMETHORPHAN HBR, GUAIFENESIN capsule, liquid filled
- NDC Code(s): 69729-781-02
- Packager: OPMX LLC
- 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 March 11, 2022
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
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 your prescription drug contains an MAOI, ask a 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 chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if:
Cough lasts for more than 7 days, recurs, 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.
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
DEXTROMETHORPHAN HBR, GUAIFENESIN
dextromethorphan hbr, guaifenesin capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-781 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) GLYCERIN (UNII: PDC6A3C0OX) GELATIN (UNII: 2G86QN327L) POVIDONE K30 (UNII: U725QWY32X) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color yellow (LIGHT YELLOW) Score no score Shape OVAL (Oblong) Size 20mm Flavor Imprint Code 781 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-781-02 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 02/18/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/18/2019 Labeler - OPMX LLC (029918743)