Acetaminophen — v3

Acetaminophen

5 Views

Version

v3

Effective date

September 22, 2025

Original packager

Yes

Sections captured

16

Identifiers

Document ID
3f5f97da-ddf9-c49d-e063-6394a90a527e
Set ID
352bb451-ffdc-411a-e063-6294a90a8cf5
Application numbers
M013
Product NDCs
35916-0183
Package NDCs
35916-0183-2, 35916-0183-3
Original packager NDCs

Names & Manufacturers

Brand names
Acetaminophen
Generic names
ACETAMINOPHEN
Manufacturer names
Softgel Healthcare Pvt Ltd
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
198439
UNII
362O9ITL9D
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each Softgel) 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

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.
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 capsules every 6 hours while symptoms last •do not take more than 6 capsules in 24 hours,unless directed by a doctor • do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor
Dosage And Administration Table (1)

Sequence 1

adults and children 12 years and over• take 2 capsules every 6 hours while symptoms last•do not take more than 6 capsules in 24 hours,unless directed by a doctor• do not use for more than 10 days unless directed by a doctor
children under 12 yearsask a doctor
Inactive Ingredient (1)

Sequence 1

Inactive ingredients FD&C red 40, gelatin,glycerin, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, povidone K30,purified water, sorbitol sorbitan solution, titanium dioxide
Indications And Usage (1)

Sequence 1

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

Sequence 1

Keep out of reach of children. Overdose warnings: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other Safety Information (1)

Sequence 1

Other information store between 20-25°C (68-77°F)
Package Label Principal Display Panel (2)

Sequence 1

Bulk Package Label Bulk label

Sequence 2

bulk 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
Spl Product Data Elements (1)

Sequence 1

Acetaminophen Acetaminophen GLYCERIN SORBITOL POLYETHYLENE GLYCOL 400 FD&C RED NO. 40 TITANIUM DIOXIDE WATER GELATIN ACETAMINOPHEN ACETAMINOPHEN POVIDONE K30 POLYOXYL 40 HYDROGENATED CASTOR OIL Opaque
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

Warnings 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.

OpenFDA raw payload

{'application_number': ['M013'],
 'brand_name': ['Acetaminophen'],
 'generic_name': ['ACETAMINOPHEN'],
 'is_original_packager': [True],
 'manufacturer_name': ['Softgel Healthcare Pvt Ltd'],
 'package_ndc': ['35916-0183-2', '35916-0183-3'],
 'product_ndc': ['35916-0183'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['198439'],
 'spl_id': ['3f5f97da-ddf9-c49d-e063-6394a90a527e'],
 'spl_set_id': ['352bb451-ffdc-411a-e063-6294a90a8cf5'],
 'substance_name': ['ACETAMINOPHEN'],
 'unii': ['362O9ITL9D']}