8 hr Pain Relief 650 mg/1

Acetaminophen · TABLET, EXTENDED RELEASE · DOLGENCORP, INC.

No Recall HistoryCurrently in Shortage

Plain English

8 hr Pain Relief is a tablet, extended release containing acetaminophen at 650 mg/1, taken oral. Manufactured by DOLGENCORP, INC..

Key Facts

Brand Name: 8 hr Pain Relief
Generic Name: Acetaminophen
NDC Code (Product): 55910-895
Manufacturer: DOLGENCORP, INC.
Strength: 650 mg/1
Dosage Form: TABLET, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: ANDA215486
Marketing Start: 04/29/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

off label use22,386 reports

fatigue20,435 reports

drug ineffective18,154 reports

pain18,106 reports

nausea17,622 reports

headache16,713 reports

toxicity to various agents15,538 reports

dyspnoea14,576 reports

arthralgia14,309 reports

pyrexia14,270 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions Do not take more than directed. See overdose warning adults and children 12 years and over • take 2 caplets every 8 hours with water • swallow whole; do not crush, chew, split, or dissolve • do not take more than 6 caplets in 24 hours • do not use for more than 10 days unless directed by a doctor children under 12 years • do not use

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 caplets 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. • 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. Over…

Frequently Asked Questions

What is 8 hr Pain Relief used for?

8 hr Pain Relief contains Acetaminophen. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is 8 hr Pain Relief a controlled substance?

8 hr Pain Relief is not classified as a controlled substance by the DEA.

What is the generic name for 8 hr Pain Relief?

The generic name for 8 hr Pain Relief is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for 8 hr Pain Relief 650 mg/1?

The NDC (National Drug Code) for 8 hr Pain Relief 650 mg/1 is 55910-895, listed by DOLGENCORP, INC..

Product NDC

55910-895

Package NDC

55910-895-05

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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