Acetaminophen , Caffeine and pyrilamine maleate

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Acetaminophen , Caffeine and pyrilamine maleate
Generic name: ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE
Manufacturer: Softgel Healthcare Pvt Ltd
Product type: HUMAN OTC DRUG
SPL set ID: 45478958-ad86-4d87-e063-6394a90a3c45
SPL ID: 500390ea-f6a3-0c41-e063-6294a90a7f35
Version: 3
Effective date: 2026-04-27
Source export date: 2026-10-12
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:29:10

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M013	openfda.application_number
brand name		Acetaminophen , Caffeine and pyrilamine maleate	openfda.brand_name
generic name		ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE	openfda.generic_name
manufacturer name		Softgel Healthcare Pvt Ltd	openfda.manufacturer_name
ndc	package	35916-0710-1	openfda.package_ndc
ndc	product	35916-0710	openfda.product_ndc
ndc11	package	35916071001	derived:openfda.package_ndc
rxcui		701913	openfda.rxcui
spl id		500390ea-f6a3-0c41-e063-6294a90a7f35	id
spl set id		45478958-ad86-4d87-e063-6394a90a3c45	set_id
unii		3G6A5W338E	openfda.unii
unii		R35D29L3ZA	openfda.unii
unii		362O9ITL9D	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 softgel in 24 hours, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: • hives • blisters • rash • skin reddening • facial swelling • asthma (wheezing) • shock If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.