FDA.reportPublic FDA data

Childrens Allergy Relief

Manufacturer
CalmCo LLC
Effective date
2024-05-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:02:03

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

this product does not contain directions or complete warnings for adult use give the recommended number of vials below following the instructions under Easy to Use on the side panel do not take more than 6 doses in any 24 hour period empty each Single-Use Vial of all liquid when dosing Dosing Chart Age (Years) Dose 6 - 11 years 1 - 2 Single-Use Vials (5mL each) every 4-6 hours. Do not exceed 12 vials in 24 hours

Label contents#

Full prescribing information#

Active Ingredient (in each 5mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCL 12.5mg

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 if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use
  • give the recommended number of vials below following the instructions under Easy to Use on the side panel
  • do not take more than 6 doses in any 24 hour period
  • empty each Single-Use Vial of all liquid when dosing

Dosing Chart

Age (Years)Dose
6 - 11 years1 - 2 Single-Use Vials (5mL 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

Other information

OTHER SAFETY INFORMATION

  • each Single-Use vial contains 16mg of sodium
  • store at 68-77ºF (20-25ºC)
  • tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken

Questions or comments?

OTC - QUESTIONS SECTION

941-202-3270 or visit www.DrKids.com

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73282-0012CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [CALMCO LLC]5Legacy NDC20240526_c8ea4c6d-19c7-894f-e053-2a95a90a30af.zip

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
73282-001273282-0012-1

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

Source Document#

Source XML

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
1934f523-5307-d72e-e063-6394a90a839ec8ea4c6d-19c7-894f-e053-2a95a90a30af2024-05-24WarningsExact identifier
spl id: 1934f523-5307-d72e-e063-6394a90a839e
spl set id: c8ea4c6d-19c7-894f-e053-2a95a90a30af

Reported adverse events (FAERS/openFDA)#

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