Diphenhydramine Hydrochloride 25mg

Manufacturer
Strive Pharmaceuticals Inc
Effective date
2022-04-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:10

Label at a glance#

ProductDiphenhydramine Hydrochloride 25mg
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
adults and children 12 years of age and overtake 1 to 2 caplets
children 6 to under 12 yearstake 1 caplet
children under 6 years of agedo not use

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

temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing

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 prostrate gland

Ask a doctor or a pharmacist before use if

you are taking sedatives or tranquilzers

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and 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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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

OTC - PURPOSE SECTION

Antihistamine

OTHER SAFETY INFORMATION

  • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
  • avoid excessive heat, cold and humidity

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

136136136-01136-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2

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
70692-136-01Diphenhydramine Hydrochloride 25mg100 in 1 PACKAGETABLET1002
70692-136-22Diphenhydramine Hydrochloride 25mg12 in 1 PACKAGETABLET122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-136DIPHENHYDRAMINE HYDROCHLORIDE 25MG TABLET [STRIVE PHARMACEUTICALS INC]2Legacy NDC, 2 package rows20220413_b43fe25c-077e-1677-e053-2a95a90a3d04.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70692-13670692-136-22, 70692-136-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
dc792777-d8b4-3ebc-e053-2a95a90abc3fb43fe25c-077e-1677-e053-2a95a90a3d042022-04-12WarningsExact identifier
spl id: dc792777-d8b4-3ebc-e053-2a95a90abc3f
spl set id: b43fe25c-077e-1677-e053-2a95a90a3d04

Reported adverse events (FAERS/openFDA)#

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