Label: GUAIFENESIN AND DEXTROMETHORPHAN HBR tablet, extended release
- NDC Code(s): 65162-039-03, 65162-039-06, 65162-039-17
- Packager: Amneal Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated December 26, 2022
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- Active ingredient(s)(in each extended-release tablet)
- 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
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
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
Stop use and ask a doctor if
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
- Other information
- Inactive ingredients
You may also report side effects to this phone number.
Learn about teen medicine abuse
Keep the carton. It contains important information.
See end panel for expiration date.
†Mucinex® is a registered trademark of Reckitt Benckiser LLC.
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
- Principal Display Panel
INGREDIENTS AND APPEARANCE
GUAIFENESIN AND DEXTROMETHORPHAN HBR
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65162-039 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 A (UNII: F68VH75CJC) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TALC (UNII: 7SEV7J4R1U) POVIDONE (UNII: FZ989GH94E) 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:65162-039-17 2 in 1 CARTON 11/01/2018 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:65162-039-03 1 in 1 CARTON 11/01/2018 2 30 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:65162-039-06 1 in 1 CARTON 11/01/2018 3 60 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 ANDA209692 11/01/2018 Labeler - Amneal Pharmaceuticals LLC (123797875) Establishment Name Address ID/FEI Business Operations Amneal Pharmaceuticals of New York, LLC 123797875 analysis(65162-039) , label(65162-039) , manufacture(65162-039) , pack(65162-039)