diphenhydramine hcl 25mg caplets

diphenhydramine hcl 25mg caplets
SPL v1
SPL
SPL Set ID d58efe7d-c8d9-4031-8d09-432a4df7518e
Route
oral
Published
Effective Date 2013-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
croscarmellose sodium d&c red no. 27 dibasic calcium phosphate dihydrate hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycols propylene glycol silicon dioxide stearic acid titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2013-05-21
Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg

Medication Information

Uses

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

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

Antihistamine

Directions
  • take every 4 to 6 hours as needed
  • do not take more than 6 times in 24 hours or as directed by a doctor

Adults and children 12 years and older

  • 1 or 2 caplets (25mg to 50mg)

Children under 12 years

  • ask a doctor
Other Information
  • Store at room temperature
  • keep lid tightly closed in dry place
  • Do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients

Croscarmellose Sodium, D&C Red #27, Dicalcium Phosphate Dihydrate, Hydroxypropyle MethylCellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Propylene Glycol, Silica, Stearic Acid and Titanium Dioxide.

Description

Diphenhydramine HCl 25 mg

Principal Display Panel

Section 50565-1

Keep out of reach of children.

Purposes

Antihistamine

Do Not Use
  • with any other product containing diphenhydramine, even one used on skin.
  • to make a child sleepy.
Drug Facts

questions?

If you have any questions or comments, or to report an adverse event, please contact (855) 729-7200.

In Case of Overdose,

get medical help or contact a Poison Control Center right away. (1-800-222-1222)

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness effect
  • 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.

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have
  • glaucoma
  • difficulty in urinating due to an enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Uses

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

  • runny nose
  • itchy, watery eyes
  • itching of the nose and throat
  • sneezing
Directions
  • take every 4 to 6 hours as needed
  • do not take more than 6 times in 24 hours or as directed by a doctor

Adults and children 12 years and older

  • 1 or 2 caplets (25mg to 50mg)

Children under 12 years

  • ask a doctor
Other Information
  • Store at room temperature
  • keep lid tightly closed in dry place
  • Do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients

Croscarmellose Sodium, D&C Red #27, Dicalcium Phosphate Dihydrate, Hydroxypropyle MethylCellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Propylene Glycol, Silica, Stearic Acid and Titanium Dioxide.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Section 50565-1 (50565-1)

Keep out of reach of children.

Purposes

Antihistamine

Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin.
  • to make a child sleepy.
Drug Facts

questions? (Questions?)

If you have any questions or comments, or to report an adverse event, please contact (855) 729-7200.

In Case of Overdose, (In case of overdose,)

get medical help or contact a Poison Control Center right away. (1-800-222-1222)

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness effect
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Caplet) (Active ingredient (in each Caplet))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • difficulty in urinating due to an enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:37.851680 · Updated: 2026-03-14T22:53:29.712463