Percogesic Original 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 Original Strength
Generic name
ACETAMINOPHEN AND DIPHENHYDRAMINE HCL
Manufacturer
Medtech Products Inc.
Product type
HUMAN OTC DRUG
SPL set ID
529974c2-0121-4892-8e47-c2c447581091
SPL ID
6a927a49-32fc-4139-b0fe-7d2520495273
Version
2
Effective date
2025-01-17
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:26:10
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 8 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 or pharmacist 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 you 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. I f you are pregnant or breast-feeding , ask a health care professional before use. Keep out of the reach of children.

Reported adverse events (FAERS/openFDA)#

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