Label: GUAIFENESIN DM- guaifenesin and dextromethorphan syrup
- NDC Code(s): 55154-5783-5
- Packager: Cardinal Health 107, LLC
- This is a repackaged label.
- Source NDC Code(s): 0121-1276
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 12, 2024
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- PURPOSE
- DESCRIPTION
- 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 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
- •
- cough that occurs with too much phlegm (mucus)
- •
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- SPL UNCLASSIFIED SECTION
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DOSAGE & ADMINISTRATION
DIRECTIONS: Follow dosage below or use as directed by a physician.
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- do not take more than 6 doses in any 24-hour period.
age dose adults and children
12 years and over10 mL (2 teaspoonfuls)
every 4 hourschildren 6 years to
under 12 years5 mL (1 teaspoonful)
every 4 hourschildren 2 years to
under 6 years2.5 mL (1/2 teaspoonful)
every 4 hourschildren under 2 years
ask a doctor
- SPL UNCLASSIFIED SECTION
- STORAGE AND HANDLING
- MANUFACTURED BY
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INGREDIENTS AND APPEARANCE
GUAIFENESIN DM
guaifenesin and dextromethorphan syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-5783(NDC:0121-1276) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCROSE (UNII: C151H8M554) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-5783-5 5 in 1 BAG 07/01/1992 1 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/01/1992 Labeler - Cardinal Health 107, LLC (118546603)