Diphenhydramine Hydrochloride

Manufacturer
Strive Pharmaceuticals Inc.
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:07:50

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

OTC - PURPOSE SECTION

Sleep-aid

INACTIVE INGREDIENT SECTION

polyethylene glycol, propylene glycol, FD&C blue # 1, FD&C red # 40, gelatin, glycerin, sorbitol 70%, povidone, purified water.

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)
  • adults and children 12 years of age and over: take 2 softgels at bedtime if needed or as directed by doctor
  • children under 12 years of age: do not use

INDICATIONS & USAGE SECTION

  • helps fall asleep faster
  • for relief of occasional sleeplessness

WARNINGS SECTION

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and night-time cold/flu products

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep-aid

When using this product

  • drowsiness may occur
  • avoid alcoholic drinks and other drugs that cause drowsiness

Stop use and ask a doctor if

  • sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

OTHER SAFETY INFORMATION

  • store at room temperature between 20-25°C (68-77ºF).
  • avoid excessive heat, cold and humidity.
  • TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

784784

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN6
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD6

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-784-02Diphenhydramine Hydrochloride20 in 1 BLISTER PACKCAPSULE, LIQUID FILLED206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-784DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [STRIVE PHARMACEUTICALS INC.]6Legacy NDC, 1 package rows20240125_96a07573-f3bd-528c-e053-2995a90a81c5.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
70692-78470692-784-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
8afba990-140d-4ab7-985a-f8ce27d8b66196a07573-f3bd-528c-e053-2995a90a81c52024-01-01WarningsExact identifier
spl id: 8afba990-140d-4ab7-985a-f8ce27d8b661
spl set id: 96a07573-f3bd-528c-e053-2995a90a81c5

Reported adverse events (FAERS/openFDA)#

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