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Acetaminophen Caplets

acetaminophen · Acetaminophen Caplets is an over-the-counter drug containing acetaminophen, made by Breeden Brothers, LLC.

Type
Over the counter
Drug class
Not classified
Route
Oral
Manufacturers
1

_ 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)

Drug facts

Generic name
acetaminophen
Active ingredients
Acetaminophen
Dosage forms
Tablet
Label holder
Breeden Brothers, LLC
FDA application
part343
Label updated
02/15/2017

Active ingredients

Act ive ingredient (in each caplet) Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

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)

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

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. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is Drug Facts (continued) critical for adults as well as for children even if you do not notice any signs or symptoms.

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

Liver disease.

Ask a doctor or pharmacist before use

Taking the blood thinning drug warfarin.

Stop use and ask a doctor

_ 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.

Pregnancy or breastfeeding

Ask a health professional before use.

Keep out of reach of children

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is Drug Facts (continued) critical for adults as well as for children even if you do not notice any signs or symptoms.

Inactive ingredients

Castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions?

1-800-901-2420 Dist. by Breeden Brothers, LLC Nashville, TN 37219

Forms and strengths

From the FDA NDC Directory · 2 product codes

Dosage formStrengthRouteNDCs
Tablet500 mgoral2

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 445,036 reports that list acetaminophen, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Drug ineffective37,633
  • Fatigue36,342
  • Off label use34,857
  • Nausea31,499
  • Headache30,238
  • Pain29,611
  • Diarrhea25,002
  • Dyspnea24,049
  • Arthralgia23,147
  • Vomiting22,036

To report a side effect, use FDA MedWatch.

Manufacturers and labels

1 FDA label

  • Breeden Brothers, LLCShown herepart343 · Label 02/15/2017 · NDC 70729-001, 70729-175Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Acetaminophen Caplets: common questions

What is Acetaminophen Caplets used for?
_ 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)
Is Acetaminophen Caplets a prescription drug?
No. Acetaminophen Caplets is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Acetaminophen Caplets?
Yes. Other FDA-listed products with the same active ingredients include Pain Reliever, Pain Relief, Childrens Pain and Fever, Pain Relief Extra Strength.
Who makes Acetaminophen Caplets?
Breeden Brothers, LLC lists Acetaminophen Caplets with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 02/15/2017 · Label text is shown as published by the manufacturer. Not medical advice