Drugplain

Pain Relief Extra Strength 500 mg/1

Acetaminophen 500 mg · TABLET · Allegiant Health

No Recall HistoryCurrently in Shortage
Plain English

Pain Relief Extra Strength is an over-the-counter tablet containing 500 mg of acetaminophen, a common pain reliever and fever reducer. This medication is taken by mouth and is used to temporarily relieve minor aches, pains, and fever.

Key Facts

Brand Name
Pain Relief Extra Strength
Generic Name
Acetaminophen 500 mg
NDC Code (Product)
69168-328
Manufacturer
Allegiant Health
Strength
500 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
12/17/2014

Recall History

No Recall History

Side Effects Reported to FDA

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

off label use22,394 reports
fatigue20,451 reports
drug ineffective18,163 reports
pain18,123 reports
nausea17,656 reports
headache16,735 reports
toxicity to various agents15,546 reports
dyspnoea14,600 reports
arthralgia14,312 reports
pyrexia14,284 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 tablets every 6 hours while symptoms last swallow whole – do not crush, chew, or dissolve do not take more than 6 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

Warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours 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. if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medica…

Frequently Asked Questions

What is Pain Relief Extra Strength used for?

Pain Relief Extra Strength is an over-the-counter tablet containing 500 mg of acetaminophen, a common pain reliever and fever reducer. This medication is taken by mouth and is used to temporarily relieve minor aches, pains, and fever.

Is Pain Relief Extra Strength a controlled substance?

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

What is the generic name for Pain Relief Extra Strength?

The generic name for Pain Relief Extra Strength is Acetaminophen 500 mg. There are 10 other brand versions of Acetaminophen 500 mg.

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

The NDC (National Drug Code) for Pain Relief Extra Strength 500 mg/1 is 69168-328, listed by Allegiant Health.

Product NDC

69168-328

Package NDC

69168-328-01

Other Acetaminophen Brands

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

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