Acetaminophen — v6

Acetaminophen

8 Views

Version

v6

Effective date

September 23, 2025

Original packager

Sections captured

19

Identifiers

Document ID
b59bb526-dff2-4b95-929e-931ac406ebd3
Set ID
9efcce86-dd57-4ea2-ad31-d2038eb61bf1
Application numbers
M013
Product NDCs
55154-7897
Package NDCs
55154-7897-0
Original packager NDCs
0904-6730

Names & Manufacturers

Brand names
Acetaminophen
Generic names
ACETAMINOPHEN
Manufacturer names
Cardinal Health 107, LLC
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ACETAMINOPHEN
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
198440
UNII
362O9ITL9D
UPC
0055154789707

Structured Label Sections

Active Ingredient (1)

Sequence 1

Drug Facts Active Ingredient (in each tablet) Acetaminophen 500 mg
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have liver disease
Ask Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Do Not Use (1)

Sequence 1

• 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
Dosage And Administration (1)

Sequence 1

Directions • do not take more than directed (see overdose warning) adults and children 12 years and over: • take 2 tablets every 6 hours while symptoms last • do not take more than 6 tablets in 24 hours, unless directed by a doctor • do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor
Inactive Ingredient (1)

Sequence 1

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Indications And Usage (1)

Sequence 1

Uses Temporarily reduces fever and relieves minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • the common cold • toothache • premenstrual and menstrual cramps
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children.
Other Safety Information (1)

Sequence 1

Other Information store in a dry place at 15° – 30°C (59° – 86°F).
Overdosage (1)

Sequence 1

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.
Package Label Principal Display Panel (1)

Sequence 1

Principal Display Panel NDC 55154-7897-0 ACETAMINOPHEN EXTRA STRENGTH TABLETS 500 mg 10 TABLETS 500mg bag label
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Pain reliever/ Fever reducer
Questions (1)

Sequence 1

Questions or comments? Call 1-800-231-4670
Spl Product Data Elements (1)

Sequence 1

Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN POVIDONE K30 STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID 54;27
Spl Unclassified Section (1)

Sequence 1

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Re-order No. 700923 M-29 Rev. 09/23 R52341 Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Overbagged with 10 tablets per bag, NDC 55154-7897-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Distributed By: Cardinal Health Dublin, OH 43017 L548143-10624 / L5488143-20624 *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol®.
Spl Unclassified Section Table (1)

Sequence 1

Re-order No. 700923M-29Rev. 09/23R52341
Stop Use (1)

Sequence 1

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.
Warnings (1)

Sequence 1

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • 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. • 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. 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.

OpenFDA raw payload

{'application_number': ['M013'],
 'brand_name': ['Acetaminophen'],
 'generic_name': ['ACETAMINOPHEN'],
 'manufacturer_name': ['Cardinal Health 107, LLC'],
 'original_packager_product_ndc': ['0904-6730'],
 'package_ndc': ['55154-7897-0'],
 'product_ndc': ['55154-7897'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['198440'],
 'spl_id': ['b59bb526-dff2-4b95-929e-931ac406ebd3'],
 'spl_set_id': ['9efcce86-dd57-4ea2-ad31-d2038eb61bf1'],
 'substance_name': ['ACETAMINOPHEN'],
 'unii': ['362O9ITL9D'],
 'upc': ['0055154789707']}