CVS Childrens

Manufacturer
CVS
Effective date
2025-12-10
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:21:40

Key Label Information#

Uses

Uses

temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat sneezing and runny nose cough temporarily reduces fever

Warnings

Warnings

Directions And Dosage

Directions

this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning ) shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age. remove the child protective cap and squeeze your child's dose into the dosing cup repeat dose every 4 hours, while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) under 36 under 4 years do not use 36-47 4 to 5 years do not use unless directed by a doctor 48-95 6 to 11 years 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Label Information

Other information

each 5 mL contains: sodium 3 mg store at room temperature TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C Red No. 33, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, microcrystalline cellulose, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

NDC 69842-792-04 CVS Health ® Compare to the active ingredients in Children’s Tylenol ® Cold + Cough + Runny Nose* Suspension Liquid Children's Cough & Runny Nose ACETAMINOPHEN, Pain Reliever-Fever Reducer CHLORPHENIRAMINE MALEATE, Antihistamine DEXTROMETHORPHAN HBr Cough Suppressant Relieves: Fever & Sore Throat Sneezing & Runny Nose Cough Dosing cup included Grape Flavor Ages 6-11 4 FL OZ (120 mL) IMPORTANT: Keep this carton for future reference on full labeling. Package contains One Bottle Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2020 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-12431 CVS ® Quality Money Back Guarantee *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children’s Tylenol ® Cold + Cough + Runny Nose.

Label Images#

childrens-01
childrens-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086750acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG in 5 mL Oral SuspensionPSN8
1086750acetaminophen 32 MG/ML / chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SuspensionSCD8
1086750acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral SuspensionSY8
1086750APAP 32 MG/ML / Chlorpheniramine Maleate 0.2 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SuspensionSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-792-04CVS ChildrensCold plus Cough plus Runny Nose1 in 1 CARTONSUSPENSION18
69842-792-04CVS ChildrensCold plus Cough plus Runny Nose120 mL in 1 BOTTLESUSPENSION1208

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-79269842-792-04

Ingredients#

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Uses

INDICATIONS & USAGE SECTION

temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat sneezing and runny nose cough temporarily reduces fever

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning ) shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age. remove the child protective cap and squeeze your child's dose into the dosing cup repeat dose every 4 hours, while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) under 36 under 4 years do not use 36-47 4 to 5 years do not use unless directed by a doctor 48-95 6 to 11 years 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

STORAGE AND HANDLING SECTION

each 5 mL contains: sodium 3 mg store at room temperature TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethylcellulose sodium, D&C Red No. 33, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, microcrystalline cellulose, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69842-792-04 CVS Health ® Compare to the active ingredients in Children’s Tylenol ® Cold + Cough + Runny Nose* Suspension Liquid Children's Cough & Runny Nose ACETAMINOPHEN, Pain Reliever-Fever Reducer CHLORPHENIRAMINE MALEATE, Antihistamine DEXTROMETHORPHAN HBr Cough Suppressant Relieves: Fever & Sore Throat Sneezing & Runny Nose Cough Dosing cup included Grape Flavor Ages 6-11 4 FL OZ (120 mL) IMPORTANT: Keep this carton for future reference on full labeling. Package contains One Bottle Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2020 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-12431 CVS ® Quality Money Back Guarantee *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children’s Tylenol ® Cold + Cough + Runny Nose.

Source Document#

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