FDA.reportPublic FDA data

CVS Health Childrens Allergy Relief

Manufacturer
CVS Pharmacy,Inc.
Effective date
2017-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:53:54

Label at a glance#

ProductCVS Health Childrens Allergy Relief
Active ingredientDiphenhydramine hydrochloride
Label structure9 sections

Indications and uses

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

Dosage and administration

• find right dose on chart below • break tab on blister • pour liquid directly into mouth or into teaspoon • be careful of blister edges to prevent cuts on skin • take every 4 to 6 hours • do not take more than 6 doses in 24 hours Age (yr) Dose (tsp) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 1 to 2 single-dose blisters(12.5mg to 25mg)

Storage and handling

• each blister contains: sodium 11 mg • store at (59-77°F) • do not use if individual single-dose blisters are torn or broken • see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL blister)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl USP 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
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • find right dose on chart below
  • break tab on blister
  • pour liquid directly into mouth or into teaspoon
  • be careful of blister edges to prevent cuts on skin
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours

Age (yr)

Dose (tsp)

children under 2 years

do not use

children 2 to 5 years

do not use unless directed by a doctor

children 6 to 11 years

1 to 2 single-dose blisters(12.5mg to 25mg)

Other information

STORAGE AND HANDLING SECTION

  • each blister contains: sodium 11 mg
  • store at (59-77°F)
  • do not use if individual single-dose blisters are torn or broken
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health ™

Compare to the active ingredient in Children's
Benadryl® *

Dye-Free Liquid

Children’s Allergy Relief

Liquid Medication

DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg

Antihistamine

alcohol and sugar free

Relief of:

  • Sneezing;
  • runny nose;
  • itchy, watery eyes;
  • itchy throat

Cherry Flavored

Sugar & Alcohol free

Actual Product size on Side Panel

Single Dose

10 SINGLE DOSE VIALS

This is not a child-resistant package. Keep out of reach of children

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children’s Benadryl® Dye –Free Allergy.

TAMPER EVIDENT: DO NOT USE IF ANY INDIVIDUAL SINGLE-DOSE BLISTER UNIT IS BROKEN OR OPEN

Distributed by: CVS Pharmacy, Inc.

One CVS Drive,Woonsocket, RI 02895

© 2015CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Made in the U.S.A.

V-12431

CVS Quality

Money Back Guarantee

SNAP BACK AT PERFORATION LINE

POUR INTO MOUTH OR SPOON

  • Use scissors to cut blister if difficult to open.
CVS Health Children's Allergy Relief 10 Single Dose Vials
CVS Health Children's Allergy Relief 10 Single Dose Vials

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN2
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD2
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY2
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY2
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-793-10CVS Health Childrens Allergy Relief10 in 1 CARTONLIQUID102
59779-793-10CVS Health Childrens Allergy Relief5 mL in 1 VIAL, SINGLE-DOSELIQUID52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-793CVS HEALTH CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY,INC.]2Current NDC, Legacy NDC, 2 package rows20171231_dbd8c221-8409-4851-a6b4-c9f5e8e346e7.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59779-79359779-793-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
Diphenhydramine hydrochlorideTC2D6JAD40ACTIB
anhydrous citric acidXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
glycerinPDC6A3C0OXIACT
POTASSIUM CITRATEEE90ONI6FFIACT
water059QF0KO0RIACT
sodium benzoateOJ245FE5EUIACT
sorbitol506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML · Source PDF

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 Health Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.dbd8c221-8409-4851-a6b4-c9f5e8e346e72017-12-30WarningsExact identifier
ndc (package): 59779-793-10
ndc (product): 59779-793
ndc11 (package): 59779079310
spl id: 1ccf7ffb-3b53-48a4-acc6-e52f249fcc05
spl set id: dbd8c221-8409-4851-a6b4-c9f5e8e346e7

Reported adverse events (FAERS/openFDA)#

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