Dye Free Infants Pain and Fever

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: Dye Free Infants Pain and Fever
Generic name: ACETAMINOPHEN
Manufacturer: WALGREENS
Product type: HUMAN OTC DRUG
SPL set ID: 0b1d88d8-56ff-9e9d-e063-6394a90a015c
SPL ID: 15b6c603-a516-cbbc-e063-6394a90a6f87
Version: 2
Effective date: 2024-04-09
Source export date: 2026-10-30
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/e1583c3c823c7746dc6fefae78ac97d01bb558f7b0936fc3b7d2e673d3319207/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:33:28

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M013	openfda.application_number
brand name		Dye Free Infants Pain and Fever	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		WALGREENS	openfda.manufacturer_name
ndc	package	0363-7015-04	openfda.package_ndc
ndc	product	0363-7015	openfda.product_ndc
ndc11	package	00363701504	derived:openfda.package_ndc
rxcui		307668	openfda.rxcui
spl id		15b6c603-a516-cbbc-e063-6394a90a6f87	id
spl set id		0b1d88d8-56ff-9e9d-e063-6394a90a015c	set_id
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 your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Reported adverse events (FAERS/openFDA)#

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