Label: GUAIFENESIN liquid
- NDC Code(s): 58657-509-16
- Packager: Method Pharmaceuticals, LLC
- 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 December 30, 2021
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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 final part341 02/09/2016 Labeler - Method Pharmaceuticals, LLC (060216698) Establishment Name Address ID/FEI Business Operations Monarch PCM, LLC 080000294 manufacture(58657-509)