Drug Catalog - Product Detail
VANATOL S SOL 325 MG/15 ML-50MG/15ML ORAL 30 ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 58809-0359-30 | GM PHARMACEUTICALS | 30 | 50-325-40MG/15ML | NA |
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Description
DESCRIPTION VANATOL ® S (butalbital, acetaminophen and caffeine) is supplied in liquid form for oral administration. Each 15 mL contains: Butalbital USP.................................................... 50 mg Warning: May be habit-forming. Acetaminophen USP.......................................... 325 mg Caffeine USP...................................................... 40 mg Alcohol ............................................................... 7.368% In addition, this drug product contains the following inactive ingredients: citric acid, ethyl maltol, liquid glucose, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with FD&C yellow #6 as coloring, and natural and artificial flavoring. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula: Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula: Butalbital Acetaminophen Caffeine
How Supplied
HOW SUPPLIED VANATOL ® S (butalbital, acetaminophen and caffeine oral solution) is an orange, tropical fruit punch flavored liquid containing butalbital 50 mg (Warning: May be habit-forming) , acetaminophen 325 mg and caffeine 40 mg per 15 mL, with 7.368% alcohol. It is supplied as follows: 1 fl oz NDC 58809-359-30 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Rx only Manufactured for: GM Pharmaceuticals, Inc. Arlington, TX 76015 Manufactured by: Mikart, Inc. Atlanta, GA 30318
Indications & Usage
INDICATIONS AND USAGE VANATOL ® S is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
Dosage and Administration
DOSAGE AND ADMINISTRATION One or two tablespoonfuls (15 mL or 30 mL) every four hours. Total daily dosage should not exceed 6 tablespoonfuls. Extended and repeated use of this product is not recommended because of the potential for physical dependence.