Acetaminophen Caplets 500 mg/1

Acetaminophen · TABLET · Breeden Brothers, LLC

No Recall HistoryCurrently in Shortage

Plain English

Acetaminophen Caplets is a tablet containing acetaminophen at 500 mg/1, taken oral. Manufactured by Breeden Brothers, LLC.

Key Facts

Brand Name: Acetaminophen Caplets
Generic Name: Acetaminophen
NDC Code (Product): 70729-175
Manufacturer: Breeden Brothers, LLC
Strength: 500 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: part343
Marketing Start: 05/01/2017

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 ineffective18,155 reports

pain18,103 reports

nausea17,623 reports

headache16,714 reports

toxicity to various agents15,539 reports

dyspnoea14,575 reports

arthralgia14,309 reports

pyrexia14,271 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions _ do not take more than directed _ adults and children 12 years and over _ take 2 caplets every 6 hours while symptoms last _ do not take more than 6 caplets in 24 hours, unless directed by a doctor _ do not take 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: _ rash _ blisters _ skin reddening If a skin reaction occurs, stop use and seek medical help right away. Do not use _ if you are allergic to acetaminophen or any of the inactive ingredients in this product _ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug Drug Facts (continued) contains acetaminophen, ask a doctor or pharmacist. 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…

Frequently Asked Questions

What is Acetaminophen Caplets used for?

Acetaminophen Caplets contains Acetaminophen. It is a tablet taken oral. Consult your doctor for specific uses.

Is Acetaminophen Caplets a controlled substance?

Acetaminophen Caplets is not classified as a controlled substance by the DEA.

What is the generic name for Acetaminophen Caplets?

The generic name for Acetaminophen Caplets is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for Acetaminophen Caplets 500 mg/1?

The NDC (National Drug Code) for Acetaminophen Caplets 500 mg/1 is 70729-175, listed by Breeden Brothers, LLC.

Product NDC

70729-175

Package NDC

70729-175-12

Other Acetaminophen Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)