FDA Label for Acetaminophen And Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
Acetaminophen And Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Cispharma, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredient (in each caplet)
Acetaminophen ..............................500 mg
Diphenhydramine HCl ......................25 mg
Uses
temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take; ■ more than 4,000 mg of acetaminophen in 24 hours; ■ with other drugs containing acetaminophen; ■ 3 or more alcoholic drinks everyday while using this product
Overdasage Warnings;
Taking more than the recommended dose (overdose) may liver damage. In case of overdose, get medical help or contact poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions: Do Not Take More Than Directed (See Overdose Warning)
adults and children 12 years and over |
|
children under 12 years |
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Other Information
- store between 20°- 25°C (68°- 77°F)
- do not use if the box is opened
Inactive Ingredients
Carnauba wax, FD&C blue # 1 al lake, FD&C blue # 2 al lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin
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