Label: MUCUS RELIEF DM- guaifenesin, dextromethorphan hbr tablet, extended release
- NDC Code(s): 55319-734-07
- Packager: Family Dollar (FAMILY WELLNESS)
- This is a repackaged label.
- Source NDC Code(s): 65162-039
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 7, 2023
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- Official Label (Printer Friendly)
- Active ingredients (in each extended-release tablet)
- Purpose
-
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
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Warnings
Do not use
- for children under12 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
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENTS IN MAXIMUM STRENGTH MUCINEX® DM*
MAXIMUM STRENGTH
MUCUS RELIEF DM
Guaifenesin 1200 mg
Expectorant
Dextromethorphan HBr 60 mg
Cough suppressant
- Controls Cough
- Thins and loosens mucus
EXTENDED-RELEASE TABLETS
*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Maximum Strength Mucinex® DM
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY
MIDWOOD BRANDS, LLC
500 VOLVO PKWY,
CHESAPEAKE, VA 23320
- Package Label
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF DM
guaifenesin, dextromethorphan hbr tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-734(NDC:65162-039) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 60 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 1200 mg Inactive Ingredients Ingredient Name Strength CARBOMER 934 (UNII: Z135WT9208) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color yellow (light yellow) Score no score Shape OVAL Size 22mm Flavor Imprint Code AN039 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-734-07 7 in 1 CARTON 07/01/2023 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209692 07/01/2023 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)