Childrens Allergy

Manufacturer
Capricorn Pharma Inc.
Effective date
2010-10-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:26:05

Label at a glance#

ProductChildrens Allergy
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Dosage and administration

Take every 4 to 6 hours Do not take more than 6 times in 24 hours Adults and Children 12 years of age and over 2 to 4 tablets Children 6 to under 12 years of age 1 to 2 tablets Children under 6 years of age Consult a doctor Children under 4 years of age Do not use

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS & USAGE SECTION

Uses For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of prostate gland

Ask a doctor before use if you are taking sedatives or tranquilizers

OTC - ASK DOCTOR SECTION

When using this product

OTC - WHEN USING SECTION

  • Avoid alcoholic beverages
  • Marked drowsiness may occur
  • Alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • Excitability may occur, especially in children
  • Be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding, ask a health professional before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take every 4 to 6 hours
  • Do not take more than 6 times in 24 hours
Adults and Children 12 years of age and over2 to 4 tablets
Children 6 to under 12 years of age1 to 2 tablets
Children under 6 years of ageConsult a doctor
Children under 4 years of ageDo not use

Other Information

SPL UNCLASSIFIED SECTION

  • Do not use if carton is opened or blister unit is broken
  • Store between 20-25°C (68-77°F).  Avoid high humidity. Protect from light.
  •  See end panel for lot number and expiration date.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aqueous ethyl cellulose dispersion, citric acid, crospovidone, D and C Red # 7 calcium lake, dibasic calcium phosphate, flavor, magnesium stearate, maltodextrin, mannitol, methacrylic acid copolymer, microcrystalline cellulose,  modified food starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, sucralose, talc, triacetin

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Capricorn Pharma

ORIGINAL DEVELOPERS AND MANUFACTURERS

NDC 66007-212-02

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S BENADRYL ALLERGY FASTMELT

Children's Allergy

Diphenhydramine HCl 12.5mg

ANTIHISTAMINE

Temporarily Relieves:

  • Sneezing
  • Itchy, Watery Eyes
  • Runny Nose
  • Itchy Throat
Cherry Flavor

RAPIDMELT
18 Fast Dissolving Tablets

Diphenhydramine HCl Antihistamine cartonDiphenhydramine HCl Antihistamine carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
882504diphenhydrAMINE HCl 12.5 MG Disintegrating Oral TabletPSN1
882504diphenhydramine hydrochloride 12.5 MG Disintegrating Oral TabletSCD1

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66007-212-022019-10-29C16284748780-1960f7f55-cd64-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66007-212-01Childrens Allergy6 in 1 BLISTER PACKTABLET61
66007-212-02Childrens Allergy3 in 1 CARTONTABLET31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66007-212CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CAPRICORN PHARMA INC.]1Legacy NDC, 2 package rows20101012_327ccd2d-dcc6-4919-83d7-51d8920b7b01.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD401
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1
AMMONIAINACTIVE INGREDIENT5138Q19F1X1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESINACTIVE INGREDIENTU72Q2I8C851
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CROSPOVIDONEINACTIVE INGREDIENT68401960MK1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP1
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4B1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D1
MANNITOLINACTIVE INGREDIENT3OWL53L36A1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8J1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6T1
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CP1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A21
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TRIACETININACTIVE INGREDIENTXHX3C3X6731

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66007-21266007-212-01, 66007-212-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 437 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AMETHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JCAPSULE, COATED / ORAL56 mgExact identifier — unii candidate
13 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, COATED / ORAL177.7 mgExact identifier — unii candidate
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OLEIC ACIDOLEIC ACID2UMI9U37CPFILM, EXTENDED RELEASE / TRANSDERMAL10 mgExact identifier — unii candidate
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METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AMETHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JCAPSULE, DELAYED RELEASE / ORAL1321 mgExact identifier — unii candidate
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MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii candidate
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MANNITOLMANNITOL3OWL53L36AINJECTION, SOLUTION / SUBCUTANEOUS99 mgExact identifier — unii candidate
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ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLGRANULE, FOR SUSPENSION / ORAL30 mgExact identifier — unii candidate
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TALCTALC7SEV7J4R1UCAPSULE, COATED, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
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MANNITOLMANNITOL3OWL53L36ASOLUTION / TOPICAL4 %w/vExact identifier — unii candidate
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MALTODEXTRINMALTODEXTRIN7CVR7L4A2DLOZENGE / ORAL175 mgExact identifier — unii candidate
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MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
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MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
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MANNITOLMANNITOL3OWL53L36AINJECTION / INTRAMUSCULAR106.6 mgExact identifier — unii candidate
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TALCTALC7SEV7J4R1UPOWDER, FOR SUSPENSION / ORAL735 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE / DENTAL1.5 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / INTRAMUSCULAR6.75 %w/vExact identifier — unii candidate
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CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / BUCCAL18 mgExact identifier — unii candidate
28 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, FILM COATED / ORAL15.12 mgExact identifier — unii candidate
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TALCTALC7SEV7J4R1UGRANULE, DELAYED RELEASE / ORAL525 mgExact identifier — unii candidate
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SUCRALOSESUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii candidate
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SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
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MANNITOLMANNITOL3OWL53L36ASOLUTION, CONCENTRATE / INTRAVENOUS220 mgExact identifier — unii candidate
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35 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, EXTENDED RELEASE / ORAL26 mgExact identifier — unii candidate
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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
557a995c-3fe4-411c-94ef-f6d4f1bd0a55327ccd2d-dcc6-4919-83d7-51d8920b7b012010-10-04WarningsExact identifier
spl id: 557a995c-3fe4-411c-94ef-f6d4f1bd0a55
spl set id: 327ccd2d-dcc6-4919-83d7-51d8920b7b01

Reported adverse events (FAERS/openFDA)#

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