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: Infants Pain and Fever
Generic name: ACETAMINOPHEN
Manufacturer: Aurohealth LLC
Product type: HUMAN OTC DRUG
SPL set ID: 6509a545-0036-460a-8f0d-b31caae17855
SPL ID: 932cb21d-d083-47c5-9690-2f7fb08f9ade
Version: 2
Effective date: 2026-05-27
Source export date: 2026-10-12
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:39:16

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		Infants Pain and Fever	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		Aurohealth LLC	openfda.manufacturer_name
ndc	package	58602-169-11	openfda.package_ndc
ndc	product	58602-169	openfda.product_ndc
ndc11	package	58602016911	derived:openfda.package_ndc
rxcui		307668	openfda.rxcui
spl id		932cb21d-d083-47c5-9690-2f7fb08f9ade	id
spl set id		6509a545-0036-460a-8f0d-b31caae17855	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.