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Drug Facts
Acetaminophen Tablet
FDA Label NDC 60687-924
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by American Health Packaging for the product Acetaminophen (NDC 60687-924). 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 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 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).
- 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
Adults:
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?
- about the drug product, call Aurobindo Pharma USA at 1-855-274-4122
- about the packaging or labeling, call American Health Packaging at 1-800-707-4621
Contains No Aspirin
Packaging Information
American Health Packaging unit dose blisters contain drug product from BluePoint Laboratories as follows:
(650 mg / 30 UD) NDC 60687-924-21 packaged from NDC 68001-495
Distributed by:
American Health Packaging
Columbus, OH 43217
8492421/0825F
Principal Display Panel – Carton – 650 Mg
NDC 60687- 924-21
Acetaminophen
Extended-releaseTablets USP
Pain Reliever/Fever Reducer
650 mg
30 Tablets (3 x 10)
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN.
Drug Facts
Active Ingredient Purpose
(in each caplet)
Acetaminophen USP, 650 mg.................Pain reliever/fever reducer
Uses
See package insert for complete Drug Facts information.
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
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.
See package insert for additional Drug Facts warnings.
Directions
• do not take more than directed, see package insert for overdose warning
and complete Drug Facts information.
Other Information• store at 20° to 25°C (68° to 77°F). Avoid excessive
heat 40°C (104°F). •
FOR YOURPROTECTION: Do not use product if
blister is torn or broken.
•USP Dissolution test is pending
Contains No Aspirin
The drug product contained in this package is from
NDC # 68001-495, BluePoint Laboratories
Distributed by: American Health Packaging
Columbus, OH 43217
792421
0492421/0825
Principal Display Panel – Blister – 650 Mg
Acetaminophen
Extended-Release
Tablet USP
Pain Reliever/
Fever Reducer
650 mg
* Please review the disclaimer below.
