[Hi-Tech Pharmacal Co., Inc.]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
Each 5 mL (1 teaspoonful) contains:
Guaifenesin ................................................ 100 mg
Acesulfame K, artificial cherry & vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.
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)
Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.
Questions or comments?
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
|Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)|
|Hi-Tech Pharmacal Co., Inc.||101196749||MANUFACTURE(50383-063)|