Label: GUAIFENESIN liquid
- NDC Code(s): 58657-509-16
- Packager: Method Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- Purpose
- Uses
-
Warnings
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
- cough that occurs with too much phlegm (mucus)
-
Directions
- do not take more than 6 doses in any 24-hour period
age dose adults and children 2 to 4 teaspoonfuls
12 years and over every 4 hours
children 6 years to 1 to 2 teaspoonfuls
under 12 years every 4 hours
children 2 years to ½ to 1 teaspoonful
under 6 years every 4 hours
children under 2 years ask a doctor
Drug Facts (continued)
- do not take more than 6 doses in any 24-hour period
- Other information
- Inactive ingredients
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GUAIFENESIN
guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58657-509 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 Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) 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:58657-509-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 02/09/2016 Labeler - Method Pharmaceuticals, LLC (060216698)