Label: GUAIFENESIN liquid
- NDC Code(s): 81033-102-05, 81033-102-10, 81033-102-51, 81033-102-52
- Packager: KESIN PHARMA CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 1, 2024
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- Official Label (Printer Friendly)
- Guaifenesin Solution 5mL
- Description
- Inactive Ingredients
- Uses
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Warnings
Warnings
Ask a doctor before us 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 emphysemaStop and ask a doctor if
• cough lasts mor than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
• you are hypersensitive to any of the ingredients
If pregnant or breast-feeding, ask a health professional before use.
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KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
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Directions
Follow dosage below or use as directed by a physician.
• Do not take more than 6 doses in any 24-hour periodAge Dose Adults and children 12 years and over 10 to 20mL (2 to 4 teaspoonfuls) every 4 hours Children 6 years to under 12 years 5 to 10mL (1 to 2 teaspoonfuls) every 4 hours Children 2 to under 6 years of age 2.5 to 5mL (1/2 to 1 teaspoonful) every 4 hours Children under 2 years of age Consult a physician -
How Supplied:
Guaifenesin Oral Solution is a clear, colorless solution with a grape flavor, free of visible foreign matter supplied in the following oral dosage forms:
NDC 81033-102-05: 5mL unit dose cup
NDC 81033-102-51: Case containing 100 unit dose cups of 5 mL packaged in 2 cartons of 50 unit dose cups each
NDC 81033-102-10: 10mL unit dose cup
NDC 81033-102-52: Case containing 100 unit dose cups of 10 mL packaged in 2 cartons of 50 unit dose cups each
NDC 81033-102-15: 15 mL unit dose cup
NDC 81033-102-53: Case containing 100 unit dose cups of 15 mL packaged in 2 cartons of 50 unit dose cups each - STORAGE
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label
- PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label
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INGREDIENTS AND APPEARANCE
GUAIFENESIN
guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81033-102 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) METHYLPARABEN (UNII: A2I8C7HI9T) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81033-102-51 50 in 1 CARTON 11/20/2023 1 NDC:81033-102-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:81033-102-52 50 in 1 CARTON 11/20/2023 2 NDC:81033-102-10 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 11/20/2023 Labeler - KESIN PHARMA CORPORATION (117447816) Establishment Name Address ID/FEI Business Operations Kesin Pharma 117447816 pack(81033-102) , label(81033-102) Establishment Name Address ID/FEI Business Operations Wittman Pharma, Inc. 830980947 manufacture(81033-102)