GUAIFENESIN- guaifenesin solution
Hi-Tech Pharmacal Co., Inc.
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.
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Active ingredient
Each 5 mL (1 teaspoonful) contains:
Guaifenesin ................................................ 100 mg
Inactive ingredients
Acesulfame K, artificial cherry & vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.
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
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).
Directions
Follow dosage below or use as directed by a physician.
- do not take more than 6 doses in any 24-hour period
| age | dose |
| 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 |
How Supplied:
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)
STORAGE
Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.
| GUAIFENESIN
guaifenesin solution |
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| Labeler - Hi-Tech Pharmacal Co., Inc. (101196749) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Hi-Tech Pharmacal Co., Inc. | 101196749 | MANUFACTURE(50383-063) | |