Diphenhydramine HCL

Manufacturer
Innovida Pharmaeutique Corporation
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:46:51

Label at a glance#

ProductDiphenhydramine HCL
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

do not take more than directed take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours  adults and children 12 years and over  1 to 2 tablets  children 6 to under 12 years  1 tablet  children under 6 years  do not use

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

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

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
  • difficulty in urination due to enlargement of the prostate gland

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

When using this product

  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness 
  • avoid alcoholic beverages
  • use caution 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
 adults and children 12 years and over 1 to 2 tablets
 children 6 to under 12 years 1 tablet
 children under 6 years do not use

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: calcium 30 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • use by expiration date on package

Inactive Ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Product labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71800-048-01EA - Each71800-0487d037e94-e824-4c5e-bba7-6841374bb40912025-05-14

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71800-04871800-048-01

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
46e1127a-56f6-d87b-e063-6394a90a0a171704006d-5cf1-4dec-bd01-2d9706fccd032025-12-26WarningsExact identifier
spl id: 46e1127a-56f6-d87b-e063-6394a90a0a17
spl set id: 1704006d-5cf1-4dec-bd01-2d9706fccd03

Reported adverse events (FAERS/openFDA)#

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