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Drug Facts
Acetaminophen Tablet
FDA Label NDC 68001-495
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bluepoint Laboratories for the product Acetaminophen (NDC 68001-495). 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 other, active ingredient (in each extended release tablet), purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Extended Release Tablet)
Acetaminophen USP 650 mg
Purpose
Pain reliever/fever reducer
Uses
- 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
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 tablets 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
- skin reddening
- blisters
- rash
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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
- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before ue 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.
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
do not take more than directed (see overdose warning).
Adults:
- take 2 tablets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 tablets in 24 hours
- do not use for more than 10 days unless directed by a doctor.
- ask a doctor
Under 18 years of age:
Other Information
- store at 20° to 25°C (68° to 77°F). Avoid excessive heat 40°C (104°F)
- do not use if carton is opened or foil inner seal is broken
- USP Dissolution test is pending
Inactive Ingredients
colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline
cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin
Questions Or Comments?
call 1-855-274-4122
Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ), Mahabubnagar (Dt)-509302, India.
For BluePoint Laboratories
Rev: 03/2021
M.L. No.: 22/MN/AP/2009/F/R
Package Label - Principal Display Panel
Acetaminophen Extended-Release tablets USP 650mg (100 tablets Carton) NDC: 68001-495-00
Acetaminophen Extended-Release tablets USP 650mg (100 tablets Container Label) NDC: 68001-495-00
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