Drugplain

Percogesic Extra Strength 500 mg/1

acetaminophen and diphenhydramine · CAPSULE, COATED · Medtech Products Inc.

No Recall HistoryCurrently in Shortage
Plain English

Percogesic Extra Strength is an over-the-counter pain reliever that combines acetaminophen for pain and fever relief with diphenhydramine, an antihistamine that can help with sleep. This medication is commonly used for minor aches and pains, especially when taken before bedtime.

Key Facts

Brand Name
Percogesic Extra Strength
Generic Name
acetaminophen and diphenhydramine
NDC Code (Product)
63029-054
Manufacturer
Medtech Products Inc.
Strength
500 mg/1
Dosage Form
CAPSULE, COATED
Route
ORAL
Marketing Status
Application #
M013
Drug Class
Histamine-1 Receptor Antagonist [EPC]
Marketing Start
07/07/2010

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

headache6 reports
drug ineffective5 reports
muscle spasms5 reports
nausea5 reports
pain5 reports
vomiting5 reports
dizziness4 reports
dyspnoea4 reports
injury4 reports
loss of consciousness4 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses: for temporary relief of minor aches and pains due to: headache backache muscular aches arthritis pain colds flu fever toothache premenstrual and menstrual cramps Temporarily relieves runny nose sneezing itchy nose and throat

Dosage & Administration

Directions Adults and children 12 years of age and older: take 2 caplets every 6 hours. Maximum daily dose is 6 tablets. Children under 12 years of age: ask a doctor.

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 tranquil…

Frequently Asked Questions

What is Percogesic Extra Strength used for?

Percogesic Extra Strength is an over-the-counter pain reliever that combines acetaminophen for pain and fever relief with diphenhydramine, an antihistamine that can help with sleep. This medication is commonly used for minor aches and pains, especially when taken before bedtime.

Is Percogesic Extra Strength a controlled substance?

Percogesic Extra Strength is not classified as a controlled substance by the DEA.

What is the generic name for Percogesic Extra Strength?

The generic name for Percogesic Extra Strength is acetaminophen and diphenhydramine. There are 12 other brand versions of acetaminophen and diphenhydramine.

What is the NDC code for Percogesic Extra Strength 500 mg/1?

The NDC (National Drug Code) for Percogesic Extra Strength 500 mg/1 is 63029-054, listed by Medtech Products Inc..

Product NDC

63029-054

Package NDC

63029-054-40

Other Acetaminophen Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)