FDA.reportPublic FDA data

Diphenhydramine HCl 25 mg

Manufacturer
Medline Industries, LP
Effective date
2021-10-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:34:01

Label at a glance#

ProductDiphenhydramine HCl 25 mg
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

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 over 1 or 2 caplets children 6 to under 12 years 1 caplet children under 6 years do not use this product for children under 6 years of age

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

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
  • itchy nose or throat

temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Directions

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 over1 or 2 caplets
      children 6 to under 12 years1 caplet
      children under 6 yearsdo not use this product for children under 6 years of age

Other information

OTHER SAFETY INFORMATION

  • each caplet contains: calcium 25 mg
  • store between 20°-25°C (68°-77°F)
  • protect from light and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-MEDLINE (633-5463)
Monday-Friday 9AM-5PM CST

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label frontlabel frontlabel backlabel back

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
53329-99053329-990-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 272LRS185U6KIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
CARNAUBA WAXR12CBM0EIZIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MAGNESIUM STEARATE70097M6I30IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYSORBATE 806OZP39ZG8HIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT

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
ea26da62-3255-4f1a-e053-2a95a90a34006bde8f0a-a388-77a7-e053-2a91aa0a04b42022-10-03WarningsExact identifier
spl set id: 6bde8f0a-a388-77a7-e053-2a91aa0a04b4

Reported adverse events (FAERS/openFDA)#

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