Diphenhydramine Hcl 25mg, Usp

Diphenhydramine Hcl 25mg, Usp
SPL v2
SPL
SPL Set ID c80f9a4c-1055-45d2-8fde-5b57fad3c82a
Route
ORAL
Published
Effective Date 2012-08-31
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 Magnesium Stearate Cellulose, Microcrystalline Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AP;135 Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2006-09-26
Description

(in each tablet) Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

(in each tablet) Diphenhydramine HCl 25 mg

Uses

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

  • runny nose
  • itchy nose or throat
  • sneezing
  • itchy, watery eyes
Warnings

Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged 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

    When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & 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.

Directions
  • take every 4-6 hours
  • do not take more than 6 doses in 24 hours
  • adults and children 12 years and over : 1-2 tablets
  • children under 12 years: ask a doctor
Active Ingredient

(in each tablet)

Diphenhydramine HCl 25 mg

Other Information
  • each tablet contains: calcium 45 mg
  • store at 15-30 °C (59-86 °F)
  • protect from moisture
Inactive Ingredients

croscarmellose sodium, D&C red# 27, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, opadry clear, titanium dioxide

Questions Or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BOKEN OR MISSING

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel

DIPHENHYDRAMINE HYDROCHLORIDE TABLETx`, USP 25 MG

ANTIHISTAMINE

NDC: 17714-135-01 – 100 MINI TABLETS

Structured Label Content

Uses

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

  • runny nose
  • itchy nose or throat
  • sneezing
  • itchy, watery eyes
Purpose

Antihistamine

Warnings

Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged 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

    When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & 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.

Directions
  • take every 4-6 hours
  • do not take more than 6 doses in 24 hours
  • adults and children 12 years and over : 1-2 tablets
  • children under 12 years: ask a doctor
Active Ingredient

(in each tablet)

Diphenhydramine HCl 25 mg

Other Information
  • each tablet contains: calcium 45 mg
  • store at 15-30 °C (59-86 °F)
  • protect from moisture
Inactive Ingredients

croscarmellose sodium, D&C red# 27, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, opadry clear, titanium dioxide

Questions Or Comments (Questions or Comments)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BOKEN OR MISSING

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

DIPHENHYDRAMINE HYDROCHLORIDE TABLETx`, USP 25 MG

ANTIHISTAMINE

NDC: 17714-135-01 – 100 MINI TABLETS

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:27.992619 · Updated: 2026-03-14T22:54:57.020531