FDA.reportPublic FDA data

CVS Dye-Free Children’s Allergy Chews

Manufacturer
CVS PHARMACY, INC.
Effective date
2026-08-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-14 00:01:15

Label at a glance#

ProductCVS PHARMACY DYE FREE Childrens Allergy Chews
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

▪  temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. ▪ runny nose ▪ itchy, watery eyes ▪ sneezing ▪ itching of the nose or throat

Dosage and administration

▪ find the right dose on chart below ▪ chew one tablet completely at the onset of symptoms. Do not swallow tablets whole. ▪ take every 4 to 6 hours, or as directed by a doctor. ▪ do not take more than 6 times in 24 hours Age (Year) Dose (chewable tablets) children under 2 years do not use  children 2 to under 5 years do not use unless directed by a doctor  children 6 to under 11 years 1 to 2 chewable tablets (12.5...

Storage and handling

▪ store at room temperature. ▪ Avoid high humidity. Protect from light.

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  •  temporarily relieves these symptoms due to hay fever or other upper respiratory allergies.
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

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

  • marked 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

  • find the right dose on chart below
  • chew one tablet completely at the onset of symptoms. Do not swallow tablets whole.
  • take every 4 to 6 hours, or as directed by a doctor.
  • do not take more than 6 times in 24 hours

Age (Year)

Dose (chewable tablets)

children under 2 years

do not use 

children 2 to under 5 years

do not use unless directed by a doctor 

children 6 to under 11 years

1 to 2 chewable tablets (12.5 mg to 25 mg)

adults and children 12 years and over

2 to 4 chewable tablets  (25 mg to 50 mg)

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature.
  • Avoid high humidity. Protect from light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Crospovidone, dextrose, flavors, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Children's Benadryl® Dye Free Allergy Chewable Tablets*

NDC 51316-153-18

Dye-Free

Children's Allergy Chews
Diphenhydramine HCl, / Antihistamine

For relief of:

  • sneezing
  • runny nose
  • itchy throat or nose
  • itchy, watery eyes

4-6 Hours/Dose

Bubblegum Flavor

Naturally and Artificially Flavored

18 Chewable Tablets

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Kenvue INC., owner of the registered trademark Children's Benadryl® Dye Free Allergy Chewable Tablets.

Distributed by:


IMPORTANT: Keep this carton for future reference on full labeling

CVS Dye Free Childrens allergy 18 CT
CVS Dye Free Childrens allergy 18 CT

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-15351316-153-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CROSPOVIDONE (120 .MU.M)68401960MKIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
POTASSIUM CITRATEEE90ONI6FFIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM POLYSTYRENE SULFONATE1699G8679ZIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-12-04full-release2026-06-01 01:20:08

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 DYE FREE Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.e6671e8b-653a-4f4e-b6f3-e31fcd14fbd72026-08-12WarningsExact identifier
ndc (package): 51316-153-18
ndc (product): 51316-153
ndc11 (package): 51316015318
spl id: 8c01c5fa-7acb-4ab3-bdf7-75bfc8e83e7f
spl set id: e6671e8b-653a-4f4e-b6f3-e31fcd14fbd7

Reported adverse events (FAERS/openFDA)#

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