Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride
SPL v1
SPL
SPL Set ID 6f1caac9-abc4-4f37-8c42-8d3fc6360ba9
Route
ORAL
Published
Effective Date 2016-03-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Butylparaben D&c Red No. 28 Fd&c Blue No. 1 Gelatin Lactose, Unspecified Form Magnesium Stearate Methylparaben Propylparaben Polysorbate 80

Identifiers & Packaging

Pill Appearance
Imprint: 44;107 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 1990-03-15
Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg

Uses
  • 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
Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours 
 adults and children 12

 years of age and over		  1 to 2 capsules
 children 6 to under 12

 years of age		  1 capsule
 children under 6

 years of age		  do not use this product

 in children under 6

 years of age


Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin 
Other Information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
  • protect from moisture 
Inactive Ingredients

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silica gel

Questions Or Comments?

1-800-616-2471

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 of 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.

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
Active Ingredient (in Each Banded Capsule)

Diphenhydramine HCl 25 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Principal Display Panel 25 Mg Capsule Blister Pack Carton Label

CommUnityCare Federally Qualified Health Centers

DIPHENHYDRAMINE

25mg/24 Caps

Date:

Name:

Dr.

USE AS DIRECTED.

123456

1/1/01

DIPHENHYDRAMINE 25mg/24 CAPS NDC 76413-306-24

Batch: 123456

Lot: 123456

Exp: 1/1/01

MAJOR

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Structured Label Content

Uses
  • 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
Purpose

Antihistamine

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours 
 adults and children 12

 years of age and over		  1 to 2 capsules
 children 6 to under 12

 years of age		  1 capsule
 children under 6

 years of age		  do not use this product

 in children under 6

 years of age


Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin 
Other Information (Other information)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
  • protect from moisture 
Inactive Ingredients (Inactive ingredients)

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silica gel

Questions Or Comments? (Questions or comments?)

1-800-616-2471

When Using This Product (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 of Breast Feeding, (If pregnant of breast-feeding,)

ask a health professional before use.

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
Active Ingredient (in Each Banded Capsule) (Active ingredient (in each banded capsule))

Diphenhydramine HCl 25 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Principal Display Panel 25 Mg Capsule Blister Pack Carton Label (PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton Label)

CommUnityCare Federally Qualified Health Centers

DIPHENHYDRAMINE

25mg/24 Caps

Date:

Name:

Dr.

USE AS DIRECTED.

123456

1/1/01

DIPHENHYDRAMINE 25mg/24 CAPS NDC 76413-306-24

Batch: 123456

Lot: 123456

Exp: 1/1/01

MAJOR

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:06.312767 · Updated: 2026-03-14T22:54:19.785916