FDA.reportPublic FDA data

Childrens Allergy Relief

Manufacturer
CVS Pharmacy
Effective date
2021-12-28
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 22:20:38

Label at a glance#

ProductChildrens Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 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

do not take more than 6 doses in any 24 hour period. give the recommended number of vials below following the instructions ....under “How to Open and Use” on the side panel. empty each Single-Use Vial required of all liquid when dosing. this product does not contain directions or complete warnings for adult use. Dosing Chart Age Dose (mL) Under 6 years Do not use unless directed by a doctor 6-11 years 1 - 2 Single...

Label contents#

Full prescribing information#

Active Ingredients (in each 5 mL)

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 • sneezing • itchy, watery eyes • 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 your child has

OTC - ASK DOCTOR SECTION

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if the child is taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

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

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24 hour period.
  • give the recommended number of vials below following the instructions ....under “How to Open and Use” on the side panel.
  • empty each Single-Use Vial required of all liquid when dosing.
  • this product does not contain directions or complete warnings for adult use.
    Dosing Chart
    Age Dose (mL)
    Under 6 years Do not use unless directed by a doctor

    6-11 years

    		1 - 2 Single-Use Vials (5 mL Each) Every 4 - 6 hours Do not exceed 12 Vials in 24 hours

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerin, Mixed Berry Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sorbitol, Strawberry Flavor, Sucralose, Tri-Sodium Citrate, Xanthan Gum.

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Other Information

SPL UNCLASSIFIED SECTION

  • each Single-Use Vial contains 15mg of sodium.
  • store at 20-25 °C (68-77 °F)
  • tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagePackage

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-26169842-261-01

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
XANTHAN GUMTTV12P4NEEIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
f0868810-9d6b-d595-e053-2a95a90a3f6437699001-8f1b-434b-ae75-bbd9c8f0f46a2022-12-23WarningsExact identifier
spl set id: 37699001-8f1b-434b-ae75-bbd9c8f0f46a

Reported adverse events (FAERS/openFDA)#

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