FDA.reportPublic FDA data

CVS Health Children's COLD + Cough & Runny Nose

Manufacturer
CVS
Effective date
2026-08-19
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-08-21 02:01:14

Label at a glance#

ProductCVS Childrens Cold plus Cough plus Runny Nose
Active ingredientAcetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide
Label structure9 sections

Indications and uses

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

Dosage and administration

• 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...

Storage and handling

• 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

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

Liver warning:

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

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

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.

CVS Health Children's Cough & Runny Nose
CVS Health Children's Cough & Runny Nose

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

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

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
Acetaminophen362O9ITL9DACTIB
Chlorpheniramine MaleateV1Q0O9OJ9ZACTIB
Dextromethorphan Hydrobromide9D2RTI9KYHACTIB
anhydrous citric acidXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
D&C red no. 339DBA0SBB0LIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C blue no. 1H3R47K3TBDIACT
FD&C red no. 40WZB9127XOAIACT
glycerinPDC6A3C0OXIACT
microcrystalline celluloseOP1R32D61UIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
water059QF0KO0RIACT
sodium benzoateOJ245FE5EUIACT
sorbitol506T60A25RIACT
sucroseC151H8M554IACT
xanthan gumTTV12P4NEEIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-12-10full-release2026-06-01 01:21:40

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
ndc (package): 69842-792-04
ndc (product): 69842-792
ndc11 (package): 69842079204
spl id: 6dd91267-524b-4c24-ac3b-a924dbddbfb3
spl set id: 7dc30e46-e289-40fc-b217-b123fee5daee

Reported adverse events (FAERS/openFDA)#

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