Acetaminophen PM

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Acetaminophen PM
Generic name
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer
Major Pharmaceuticals
Product type
HUMAN OTC DRUG
SPL set ID
786dbcd5-f5c2-4491-e053-2991aa0a3437
SPL ID
52fac64b-8e53-d7b7-e063-6294a90a3b71
Version
6
Effective date
2026-05-29
Source export date
2026-08-01
Source partition
14
Source file
https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/a02fd54f2831abedf72de26b709069bc80ecbb9303a4823ffe5695ea1bb3d85a/drug-label-0014-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:40:14
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

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 every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away. Do not use ■ with any other product containing diphenhydramine, even one used on skin ■ in children under 12 years of age ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have ■ liver disease ■ a breathing problem such as emphysema or chronic bronchitis ■ difculty in urination due to enlargement of the prostate gland ■ glaucoma Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers When using this product ■ avoid alcoholic beverages ■ do not drive a motor vehicle or operate machinery ■ drowsiness will occur Stop use and ask a doctor if ■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. ■ new symptoms occur ■ redness or swelling is present ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.