FDA.reportPublic FDA data

CVS Children's Cold & Allergy

Manufacturer
CVS PHARMACY, INC.
Effective date
2026-08-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-18 02:02:36

Label at a glance#

ProductCVS PHARMACY Childrens Cold and Allergy
Active ingredientBROMPHENIRAMINE MALEATE
Label structure9 sections

Indications and uses

▪ temporarily relieves: ▪ runny nose ▪ sneezing ▪ itchy, watery eyes due to hay fever ▪ itching of the nose or throat

Dosage and administration

▪ do not take more than 6 doses in any 24-hour period ▪ measure only with dosage cup provided ▪ keep dosage cup with product ▪ ml = milliliter age Dose adults and children 12 years and over 20 ml every 4 hours children 6 to under 12 years 10 ml every 4 hours children under 6 years do not use

Label contents#

Full prescribing information#

Active Ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Brompheniramine maleate, USP 2 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves:
    • runny nose
    • sneezing
    • itchy, watery eyes due to hay fever
    • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to sedate a child or to make a child sleepy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema, or chronic bronchitis.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosage cup provided
  • keep dosage cup with product
  • ml = milliliter
ageDose

adults and children 12 years and over

20 ml every 4 hours

children 6 to under 12 years

10 ml every 4 hours

children under 6 years

do not use

Other information

SPL UNCLASSIFIED SECTION

  • each 10 ml contains: sodium 6 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Children’s Dimetapp® Cold & Allergy*

NDC# 51316-693-04

Children'sCold & Allergy

Brompheniramine Maleate USP (Antihistamine)
Relieves + comforts:

  • Runny Nose
  • Itchy, Watery Eyes
  • Sneezing
  • Itchy throat

For Ages 6 Years and Over

Grape Flavor

Naturally and Artificially Flavored

No Added Alcohol

No Added Sugar

4 FL OZ (118 ml)

IMPORTANT: Keep this carton for future reference on full labeling.

Distributed by:

*This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children’s Dimetapp® Cold & Allergy.

CVS Childrens Cold and Allergy Relief 4 FL OZ 118 ml
CVS Childrens Cold and Allergy Relief 4 FL OZ 118 ml

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-69351316-693-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BROMPHENIRAMINE MALEATEIXA7C9ZN03ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-06-03full-release2026-06-01 01:02:04

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 PHARMACY Childrens Cold and AllergyBROMPHENIRAMINE MALEATECVS PHARMACY, INC.004e104b-d6ff-48d5-8685-cd1bff45399a2026-08-14WarningsExact identifier
ndc (package): 51316-693-04
ndc (product): 51316-693
ndc11 (package): 51316069304
spl id: 7496b83a-c499-46ff-8e48-bd1fe1ddf876
spl set id: 004e104b-d6ff-48d5-8685-cd1bff45399a

Reported adverse events (FAERS/openFDA)#

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