Vitapirena

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
Vitapirena
Generic name
ACETAMINOPHEN
Manufacturer
Pharmadel LLC
Product type
HUMAN OTC DRUG
SPL set ID
0547bc1f-d000-f5a6-e063-6294a90ac73d
SPL ID
468fc0a7-2a13-5c91-e063-6294a90af9a2
Version
3
Effective date
2025-12-22
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:34:59
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: adult takes more than 8 packets in 24 hours, which is the maximum daily amount for this product child takes more than 5 packets in 24 hours with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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. if allergic to acetaminophen or any other of the inactive ingredients in this product Ask a doctor before use if the user has liver disease is a child with pain from arthritis Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin Stop use and ask a doctor if adult’s pain gets worse or lasts more than 10 days child’s pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of an accidental overdose, get medical help or contact a Poison Control Center right away. 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.