Percogesic Extra Strength

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
Percogesic Extra Strength
Generic name
ACETAMINOPHEN AND DIPHENHYDRAMINE
Manufacturer
Medtech Products Inc.
Product type
HUMAN OTC DRUG
SPL set ID
2c5f1140-fb83-42c9-b0b1-5e2bd69340bb
SPL ID
dd068345-eb74-40b1-80b5-ef9df6fde1cd
Version
1
Effective date
2024-02-01
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 05:28:06
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 6 tablets 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 blisters rash. If a skin reaction occurs, stop use and seek medical help right away. 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 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 trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if your are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may cause drowsiness may cause excitability, especially in children be careful driving a motor vehicle or operating machinery. Stop use and ask a doctor if pain persists for more than 10 days fever persists for more than 3 days (unless directed by a doctor) condition worsens or new symptoms occur redness or swelling is present. These may be signs of a serious condition. If you are pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage.

Reported adverse events (FAERS/openFDA)#

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