Active Ingredient (In Each Caplet)
Acetaminophen 500 mg
Acetaminophen Caplets Tablet
FDA Label NDC 70729-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Breeden Brothers, Llc for the product Acetaminophen Caplets (NDC 70729-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use, ask a doctor or pharmacist before use, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
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.
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
Other Information
_ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
_ use by expiration date on package
Drug Facts (continued)
Inactive Ingredients
castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid
Questions Or Comments?
1-800-901-2420
Dist. by Breeden Brothers, LLC
Nashville, TN 37219
Principal Display Panel
b+b
better by giving
EXTRA STRENGTH
PAIN RELIEVER
acetaminophen
Pain Reliever/Fever Reducer
50 Caplets
(500 mg each)
Principal Display Panelb+bbetter By Givingextra Strengthpain Relieveracetaminophenpain Reliever/fever Reducer50 Caplets(500 mg Each) (Acetaminophen Caplets 01)
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