Pain Relief 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
Pain Relief PM
Generic name
ACETAMINOPHEN, DIPHENHYDRAMINE HCL
Manufacturer
HyVee Inc
Product type
HUMAN OTC DRUG
SPL set ID
4f45a750-1220-4a81-801e-bf08c9d117d6
SPL ID
e51575cc-8d80-47d9-93b7-96c19ce5f4d3
Version
7
Effective date
2026-07-16
Source export date
2026-10-27
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 20:16:13
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

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 • 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. • with any other product containing diphenhydramine, even one used on skin • 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 • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers When using this product • drowsiness will occur • avoid alcoholic drinks • do not drive a motor vehicle or operate machinery Stop use and ask a doctor if • new symptoms occur • sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present 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 right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.