Label: GUAIFENESIN AND DEXTROMETHORPHAN HBR tablet, extended release
- NDC Code(s): 51316-009-01
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated August 1, 2023
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- Active ingredients
- 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.
- do not crush, chew, or break tablet
- take with a full glass of water
- this product can be administered without regard for timing of meals
- children under 12 years of age: do not use
For 600 mg/30 mg:
- adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION
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:51316-009 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 CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958) HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) Product Characteristics Color WHITE (white to off white) , GREEN (light green to green) Score no score Shape OVAL Size 16mm Flavor Imprint Code 3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-009-01 5 in 1 CARTON 08/15/2023 1 20 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 ANDA217340 08/15/2023 Labeler - CVS Pharmacy (062312574)