Active Ingredient
(in each caplet)
Acetaminophen USP, 650 mg
Acetaminophen
FDA Label NDC 68016-183
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Acetaminophen (NDC 68016-183). 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, purpose, uses (for muscle aches & pain), uses (for arthritis pain), liver warning, allergy alert, do not use, ask a doctor before use if you have, 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 (For Muscle Aches & Pain)
■ temporarily relieves minor aches and pains due to:
■ muscular aches
■ backache
■ minor pain of arthritis
■ toothache
■ premenstrual and menstrual cramps
■ headache
■ the common cold
■ temporarily reduces fever
Uses (For Arthritis Pain)
■ temporarily relieves minor aches and pains due to:
■ minor pain of arthritis
■ muscular aches
■ backache
■ premenstrual and menstrual cramps
■ the common cold
■ headache
■ toothache
■ temporarily reduces fever
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
Keep out of reach of children
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions (For Muscle Aches & Pain)
■ do not take more than directed (see overdose warning)
adults and children 12 years of age 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 of age
■ do not use
Directions (For Arthritis Pain)
■ d o not take more than directed (see overdose warning)
adults
■ 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
under 18 years of age
■ ask a doctor
Other Information
■ store between 20-25°C (68-77°F)
■ do not use if foil inner seal is broken or missing
Inactive Ingredients
hydroxy ethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.
Questions Or Comments?
Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
For Muscle Aches & Pain
50ct (300000485 R 00 Final)
For Arthritis Pain
50 Ct (300000487 R 00 Final)
100ct (300000489 R 00 Final)
* Please review the disclaimer below.
