Label: MEDIQUE MEDI-MUCUS- dextromethorphan hbr, guaifenesin tablet
- NDC Code(s): 47682-432-46, 47682-432-50
- Packager: Unifirst First Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 7, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
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 irritations as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get sleep
- WARNINGS
-
DO NOT USE
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 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 DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MEDIQUE MEDI-MUCUS
dextromethorphan hbr, guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-432 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg Inactive Ingredients Ingredient Name Strength MALTODEXTRIN (UNII: 7CVR7L4A2D) POVIDONE (UNII: FZ989GH94E) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape OVAL Size 16mm Flavor Imprint Code AH;432 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-432-50 50 in 1 BOX 05/01/2023 1 NDC:47682-432-46 1 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-432-46 1 in 1 PACKET; Type 0: Not a Combination Product 05/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2023 Labeler - Unifirst First Aid Corporation (832947092) Establishment Name Address ID/FEI Business Operations Prestige Packaging 080667761 pack(47682-432) Establishment Name Address ID/FEI Business Operations Medique Products 086911794 pack(47682-432)