CVS CHILDRENS COLD PLUS COUGH PLUS RUNNY NOSE- acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide suspension 
CVS

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CVS Health Children's COLD + Cough & Runny Nose

Drug Facts

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

Uses

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

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.

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

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

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.

Keep out of reach of children.

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.

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 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.

CVS Health Children's Cough & Runny Nose
CVS CHILDRENS  COLD PLUS COUGH PLUS RUNNY NOSE
acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-792
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen160 mg  in 5 mL
Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate1 mg  in 5 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
D&C red no. 33 (UNII: 9DBA0SBB0L)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
FD&C red no. 40 (UNII: WZB9127XOA)  
glycerin (UNII: PDC6A3C0OX)  
microcrystalline cellulose (UNII: OP1R32D61U)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitol (UNII: 506T60A25R)  
sucrose (UNII: C151H8M554)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-792-041 in 1 CARTON03/30/2020
1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/30/2020
Labeler - CVS (062312574)

Revised: 6/2022
 
CVS