Acetaminophen by American Health Packaging ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by American Health Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60687-924(NDC:68001-495)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white ((White to Off-White))	Score	no score
Shape	CAPSULE ((Caplet))	Size	19mm
Flavor		Imprint Code	I;06
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60687-924-21	30 in 1 CARTON	02/01/2026
1	NDC: 60687-924-11	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA207229	02/01/2026

Labeler - American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Business Operations
American Health Packaging		929561009	repack(60687-924)