Premsyn pms Premenstrual Pain Relief

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
Premsyn pms Premenstrual Pain Relief
Generic name
ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE
Manufacturer
Focus Consumer Healthcare, LLC
Product type
HUMAN OTC DRUG
SPL set ID
5b6f6260-69ae-cfeb-e053-2a91aa0a6b49
SPL ID
32bde825-4a2d-de16-e063-6394a90a7941
Version
8
Effective date
2025-04-14
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:37:18
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Allergy Warning: 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. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets 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 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. Ask a doctor before use if you have: liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargment of the prostate gland. Ask a doctor or pharmacist before use if you are: taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product, you may get drowsy, avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving or operating machinery excitability may occur, especially in children stop use and ask doctor if: Pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present If pregnant or breastfeeding, ask a health professional before use. 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. Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product you may get drowsy, avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving or operating machinery excitability may occur, especially in children Stop use and ask a doctor if pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a 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.

Reported adverse events (FAERS/openFDA)#

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