Acetaminophen
- Dosage form
- TABLET
- Labeler
- American Health Packaging
- Label updated
- 2026-02-04
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN
Label information
Drug Facts
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
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 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.
Under 18 years of age:
- ask a doctor
Other information
- store at 20º to 25ºC (68º to 77ºF). Avoid excessive heat 40ºC (104ºF)
- 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
[Image in the official label — see DailyMed source]
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 YOUR
PROTECTION: 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
[Image in the official label — see DailyMed source]
Acetaminophen
Extended-Release
Tablet USP
Pain Reliever/
Fever Reducer
650 mg
DailyMed Set ID: 88e5345a-f240-473c-b329-2b0aa5f081f9 · Version 1
NDC: 60687-924