NOTTS - 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
NOTTS - Pain Relief PM
Generic name
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer
VIVUNT PHARMA LLC
Product type
HUMAN OTC DRUG
SPL set ID
e6754f62-e3b2-773f-e053-2a95a90ad36a
SPL ID
284f426f-6cb5-4e7e-e063-6294a90a946e
Version
9
Effective date
2024-12-02
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:33:00
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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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, which is the maximum daily amount. 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 rash blisters If a skin reaction occurs, stop use and seek medical attention immediately. Do not use 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 in children under 12 years of age if you are allergic to any other ingredient in this product. Ask a doctor before use if you have liver disease breathing problems such as emphysema or chronic bronchitis glaucoma difficulty in urinatation due to enlargement of the prostate gland When using this product avoid alcoholic drinks Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin sedatives or tranquilizers Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. pain lasts more than 10 days pain gets worse new symptoms occur 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 Do not take more the recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. Prompt 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.