Label: GUAIFENESIN DM- guaifenesin and dextromethorphan hydrobromide tablet
- NDC Code(s): 43063-801-30, 43063-801-60, 43063-801-90
- Packager: PD-Rx Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 16103-381
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 2, 2023
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- Official Label (Printer Friendly)
- Active ingredients (in each tablet)
- Purpose
- Uses
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Warnings
Do not use
- 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 MAOI drug. If you do not know whether your prescription drug contains MAOI, ask your doctor or pharmacist before using 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 occure with fever, rash or persistent headache
These could be signs of serious illness.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- take with a full glass of water
- this product can be administered without regard for the timing of meals
- do not exceed 6 doses in 24 hours or as directed by doctor
adults and children 12 years of age and over
take 1 tablet every 4 hours as needed
children 6 to under 12 years of age
take ½ tablet every 4 hours as needed
children under 6 years of age
consult a doctor
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GUAIFENESIN DM
guaifenesin and dextromethorphan hydrobromide tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43063-801(NDC:16103-381) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape CAPSULE (CAPSULE SHAPED TABLET) Size 18mm Flavor Imprint Code PH073 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43063-801-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/02/2018 11/30/2027 2 NDC:43063-801-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/02/2018 11/30/2027 3 NDC:43063-801-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/02/2018 11/30/2027 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/02/2018 11/30/2027 Labeler - PD-Rx Pharmaceuticals, Inc. (156893695) Registrant - PD-Rx Pharmaceuticals, Inc. (156893695) Establishment Name Address ID/FEI Business Operations PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-801)
