Allergy

Manufacturer
Mckesson
Effective date
2016-12-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:13

Label at a glance#

ProductAllergy
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

take every 4 to 6 hours do not take more than 6 tablets in 24 hours Age (Yr) Dose (capsules) Adults and children 12 years of age and over Take 1 to 2 capsules Children 6 to under 12 years of age Take 1 capsule Children under 6 years of age do not use

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(per capsule)

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • itching of the nose or throat
  • sneezing
  • itchy, watery eyes

    temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing

Warnings

WARNINGS SECTION

Do not use

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

    Ask a doctor before use if you have

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

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

    When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & 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, 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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours
  • do not take more than 6 tablets in 24 hours
    Age (Yr) Dose (capsules)
    Adults and children 12 years of age and overTake 1 to 2 capsules
    Children 6 to under 12 years of ageTake 1 capsule
    Children under 6 years of agedo not use

Other Information

SPL UNCLASSIFIED SECTION

  • store at room temperature between 15°-30°C (59°-86°F)
  • protect from light and moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzyl alcohol, Butyl paraben, D&C red # 28, FD&C blue # 1, FD&C  red # 40, Edible black ink, gelatin, lactose, Magnesium stearate, Methyl paraben, polysorbate 80, Propyl paraben, Purified water, Sodium lauryl sulfate, Starch

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4cc94678-figure-01
4cc94678-figure-01
4cc94678-figure-02
4cc94678-figure-02

NDC 70677-0010-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN1
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1

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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70677-0010-12020-01-31C16284748780-19d75b9d0-191e-f424-e053-dadaa90a57ceDIPHENHYDRAMINE HCl 25mg, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-0010-1Allergy1 in 1 CARTONCAPSULE11
70677-0010-1Allergy100 in 1 BOTTLECAPSULE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0010ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [MCKESSON]1Legacy NDC, 2 package rows20161219_d8c2dc53-7fbd-461c-b0c8-dac14a5d995a.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-001070677-0010-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
4cc94678-3221-40f1-b068-d133fd59eb5bd8c2dc53-7fbd-461c-b0c8-dac14a5d995a2016-12-17WarningsExact identifier
spl id: 4cc94678-3221-40f1-b068-d133fd59eb5b
spl set id: d8c2dc53-7fbd-461c-b0c8-dac14a5d995a

Reported adverse events (FAERS/openFDA)#

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