Label: EQUALINE MUCUS DM- dextromethorphan hbr, guaifenesin tablet, extended release
- NDC Code(s): 41163-781-66
- Packager: United Natural Foods, Inc. dba UNFI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 2, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each extended-release tablet)
- Purposes
-
Uses
- •
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- •
- temporarily relieves:
- •
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- •
- the intensity of coughing
- •
- the impulse to cough to help you get to sleep
- Warnings
-
Do not use
- •
- for children under 12 years of age
- •
- 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
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
EQUALINE MUCUS DM
dextromethorphan hbr, guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-781 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 1200 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 60 mg Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) COPOVIDONE K25-31 (UNII: D9C330MD8B) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color YELLOW (light) Score no score Shape OVAL Size 22mm Flavor Imprint Code L812 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-781-66 1 in 1 CARTON 02/24/2020 1 14 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207602 02/24/2020 Labeler - United Natural Foods, Inc. dba UNFI (943556183)