Label: MUCUS RELIEF DM EXTENDED RELEASE CAPLETS- guaifenesin, dextromethorphan hbr tablet
- NDC Code(s): 0536-1161-34, 0536-1161-37
- Packager: Rugby Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 16, 2022
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- Official Label (Printer Friendly)
- Active ingredients (in each extended-release tablet)
- Purpose
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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?
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Principal Display Panel
Compare to the active ingredients in Mucinex® DM*
Mucus Relief DM ER
Guaifenesin 600 mg
Expectorant HBr 30 mg
Dextromethorphan HBr 30 mg
Cough suppressant
- 12-hour relief
- Controls cough
- Thins & Loosens mucus
Extended-release tablets
*This product is not manufactured or distributed Reckitt Benckiser LLC, distributor of 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:
Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
- Package Label
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF DM EXTENDED RELEASE CAPLETS
guaifenesin, dextromethorphan hbr tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1161 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 600 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CARBOMER 934 (UNII: Z135WT9208) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color yellow Score no score Shape OVAL Size 16mm Flavor Imprint Code AN038 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1161-34 20 in 1 CARTON 12/13/2018 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0536-1161-37 40 in 1 CARTON 12/13/2018 2 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 12/13/2018 Labeler - Rugby Laboratories, Inc. (079246066)