Label: GUAIFENESIN solution
50383-063-10, view more50383-063-11, 50383-063-12, 50383-063-15, 50383-063-17, 50383-063-18
- Packager: Akorn
- 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.
Updated November 15, 2022
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- Active ingredient
- Inactive ingredients
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
Stop use and ask a doctor if
- cough lasts more 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
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).
Follow dosage below or use as directed by a physician.
- do not take more than 6 doses in any 24-hour period
adults and children 12 years and over
10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours
children 6 years to under 12 years
5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours
children 2 to under 6 years of age
2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours
children under 2 years of age
ask a doctor
Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose, 15 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottle
Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
- Questions or comments?
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INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50383-063 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 ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ASPARTAME (UNII: Z0H242BBR1) HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color Score Shape Size Flavor CHERRY (artificial cherry flavor) , VANILLA (artificial vanilla flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50383-063-06 4 in 1 CASE 03/07/2012 06/05/2017 1 NDC:50383-063-05 10 in 1 TRAY 1 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:50383-063-07 10 in 1 CASE 03/07/2012 2 10 in 1 TRAY 2 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 3 NDC:50383-063-11 4 in 1 CASE 03/07/2012 06/05/2017 3 NDC:50383-063-10 10 in 1 TRAY 3 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 4 NDC:50383-063-12 10 in 1 CASE 03/07/2012 4 10 in 1 TRAY 4 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 5 NDC:50383-063-17 4 in 1 CASE 03/07/2012 06/05/2017 5 NDC:50383-063-15 10 in 1 TRAY 5 15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 6 NDC:50383-063-18 10 in 1 CASE 03/07/2012 6 10 in 1 TRAY 6 15 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 final part341 03/07/2012 Labeler - Akorn (117696873) Registrant - Akorn Operating Compnay LLC (117693100) Establishment Name Address ID/FEI Business Operations Akorn 117696873 MANUFACTURE(50383-063) , PACK(50383-063)