Acetaminophen Diphenhydramine HCl

Acetaminophen Diphenhydramine HCl is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN DIPHENHYDRAMINE HCL. It is labelled by Chain Drug Consortium,LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 68016-654, application part343, label effective 20170207. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ACETAMINOPHEN DIPHENHYDRAMINE HCL are most often described in connection with: temporary relief, occasional headaches, minor aches, accompanying sleeplessness. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Directions ■ do not take more than directed (see overdose warning) adults and children 12 years and over - take 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 product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Warnings

What is Acetaminophen Diphenhydramine HCl used for?
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Who makes Acetaminophen Diphenhydramine HCl?
Chain Drug Consortium,LLC is the labeler of record for Acetaminophen Diphenhydramine HCl.

What form does Acetaminophen Diphenhydramine HCl come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Acetaminophen Diphenhydramine HCl prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Acetaminophen Diphenhydramine HCl been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.