Acetaminophen And Diphenhydramine Hydrochloride
FDA Label NDC 52204-124

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cispharma, Inc for the product Acetaminophen And Diphenhydramine Hydrochloride (NDC 52204-124). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, uses, warnings, overdasage warnings;, directions: do not take more than directed (see overdose warning), other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

  • 2 caplets at bedtime
  • do not take more than 2 caplets of this product in 24 hours

children under 12 years

  • do not use this adult product in children under 12 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage.

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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