Childrens Tukol Multi-Symptom Cold and Flu

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: Childrens Tukol Multi-Symptom Cold and Flu
Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Manufacturer: Genomma Lab USA, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 85fe6f0f-41c8-44d3-a34a-355938da5f72
SPL ID: 4aa9c4b3-12e4-4e80-9765-be13234ba585
Version: 6
Effective date: 2024-01-11
Source export date: 2026-10-30
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/2026-10-30/9dea423b9e87a781c152bc6e136923fb91acb0732a7a0ec0d2a51142148f160c/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:41:23

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Childrens Tukol Multi-Symptom Cold and Flu	openfda.brand_name
generic name		ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Genomma Lab USA, Inc.	openfda.manufacturer_name
ndc	package	50066-519-24	openfda.package_ndc
ndc	product	50066-519	openfda.product_ndc
ndc11	package	50066051924	derived:openfda.package_ndc
rxcui		1116572	openfda.rxcui
spl id		4aa9c4b3-12e4-4e80-9765-be13234ba585	id
spl set id		85fe6f0f-41c8-44d3-a34a-355938da5f72	set_id
unii		9D2RTI9KYH	openfda.unii
unii		04JA59TNSJ	openfda.unii
unii		362O9ITL9D	openfda.unii
unii		495W7451VQ	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 cantains acetaminophen. Severe liver damage may occur if your child takes more tha 5 doses in 24 hours which is the maxium daily amount with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If skin reaction occurs, stop use and seek medical help right away. Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomitting, consult a doctor promptly.

Reported adverse events (FAERS/openFDA)#

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