Acetaminophen Aspirin Caffeine

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 Aspirin Caffeine
Generic name: ACETAMINOPHEN ASPIRIN CAFFEINE
Manufacturer: WALGREEN CO
Product type: HUMAN OTC DRUG
SPL set ID: c32c8cbd-5775-afe3-e053-2995a90a81cb
SPL ID: 4654a1f1-bfdb-209e-e063-6394a90a1bd2
Version: 6
Effective date: 2025-12-19
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:44:50

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 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	214039	derived:openfda.application_number
application number		ANDA214039	openfda.application_number
brand name		Acetaminophen Aspirin Caffeine	openfda.brand_name
generic name		ACETAMINOPHEN ASPIRIN CAFFEINE	openfda.generic_name
manufacturer name		WALGREEN CO	openfda.manufacturer_name
ndc	package	0363-9680-10	openfda.package_ndc
ndc	package	0363-9680-24	openfda.package_ndc
ndc	product	0363-9680	openfda.product_ndc
ndc11	package	00363968024	derived:openfda.package_ndc
ndc11	package	00363968010	derived:openfda.package_ndc
rxcui		308297	openfda.rxcui
spl id		4654a1f1-bfdb-209e-e063-6394a90a1bd2	id
spl set id		c32c8cbd-5775-afe3-e053-2995a90a81cb	set_id
unii		3G6A5W338E	openfda.unii
unii		R16CO5Y76E	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 2 of 2 · 7 matching rows.

warnings

Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed

warnings

Medication overuse headache warning Headaches may worsen if this product is used for 10 or more days per month.

warnings

Caffeine warning The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally rapid heart beat.

Reported adverse events (FAERS/openFDA)#

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

Acetaminophen Aspirin Caffeine

openFDA label record#

Harmonized identifier links#

Related Records#

Warnings cross-check#

warnings

warnings

warnings

Reported adverse events (FAERS/openFDA)#