Cvs Health Children's Cold + Cough & Runny Nose

SPL v8

SPL

SPL Set ID 7dc30e46-e289-40fc-b217-b123fee5daee

Route

ORAL

Published

Effective Date 2025-12-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg) Chlorpheniramine (1 mg) Dextromethorphan (5 mg)

Inactive Ingredients

Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified D&c Red No. 33 Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Microcrystalline Cellulose Propyl Gallate Propylene Glycol Water Sodium Benzoate Sorbitol Sucrose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-03-30

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 55105-1

Active ingredients (in each 5 mL)	Purposes
Acetaminophen 160 mg	Pain reliever/fever reducer
Chlorpheniramine maleate 1 mg	Antihistamine
Dextromethorphan HBr 5 mg	Cough suppressant

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.

Do Not Use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
to make a child sleepy
in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
if your child has ever had an allergic reaction to this product or any of its ingredients

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

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

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.

When Using This Product

do not exceed recommended dose (see overdose warning)
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children

Stop Use and Ask A Doctor If

pain or cough gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present
cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Ask A Doctor Before Use If Your Child Has

liver disease
a breathing problem such as chronic bronchitis
glaucoma
persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 55105-1 (55105-1)

Active ingredients (in each 5 mL)	Purposes
Acetaminophen 160 mg	Pain reliever/fever reducer
Chlorpheniramine maleate 1 mg	Antihistamine
Dextromethorphan HBr 5 mg	Cough suppressant

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.

Do Not Use (Do not use)

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
to make a child sleepy
in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
if your child has ever had an allergic reaction to this product or any of its ingredients

Liver Warning: (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

Overdose Warning (Overdose warning)

Other 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 (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel (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

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.

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning)
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

pain or cough gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present
cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease
a breathing problem such as chronic bronchitis
glaucoma
persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:34.827429 · Updated: 2026-03-14T23:11:11.874697