SPL v2
SPL
SPL Set ID 44a36fdb-23bc-2b67-e063-6294a90aa77b
Route
ORAL
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Acetaminophen USP 500mg


Medication Information

Warnings and Precautions

keep out of reach of children and for further packing

Indications and Usage

Anti Inflamatory

Dosage and Administration

anti-inflamatory and for further packing 

Description

Acetaminophen USP 500mg

Section 50565-1

keep out of reach of children

Section 51727-6

Hypromellose, Magnesium stearate, Microcrystalline Cellulose , Pregelatinized Starch, Polyethylene Glycol, Povidone , Stearic Acid powder,Titanium Dioxide, Talc,

Section 51945-4

Label

Section 55105-1

for further packing and labelling 

Section 55106-9

Acetaminophen USP 500mg


Structured Label Content

Indications and Usage (34067-9)

Anti Inflamatory

Dosage and Administration (34068-7)

anti-inflamatory and for further packing 

Warnings and Precautions (34071-1)

keep out of reach of children and for further packing

Section 50565-1 (50565-1)

keep out of reach of children

Section 51727-6 (51727-6)

Hypromellose, Magnesium stearate, Microcrystalline Cellulose , Pregelatinized Starch, Polyethylene Glycol, Povidone , Stearic Acid powder,Titanium Dioxide, Talc,

Section 51945-4 (51945-4)

Label

Section 55105-1 (55105-1)

for further packing and labelling 

Section 55106-9 (55106-9)

Acetaminophen USP 500mg


Raw Label Data

All Sections (JSON)