SPL v3
SPL
SPL Set ID 7b000478-649d-4511-b3e0-eea6995b9784
Route
ORAL
Published
Effective Date 2025-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Magnesium Stearate Microcrystalline Cellulose D&c Red No. 28 Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: D25 Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-01

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:  

     o runny nose

     o sneezing

     o itchy, watery eyes

     o itchy nose or throat

  • temporarily relieves these symptoms of the common cold:

    o runny nose

    o sneezing

Warnings

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

  • trouble urinating due to an enlarged prostate gland
  • glaucoma 
  • a breathing problem such as emphysema or chronic bronchitis

Ask your doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take not more than 6 times in 24 hours
  • adults and children 12 years  and over: 1 or 2 tablets
  • children 6 to under 12 years: 1 tablet
  • children under 6 years: do not use
Questions ?

call toll-free 1-844-912-4012

Other Information
  • each tablet contains:calcium 30 mg
  • each tablet contains:phosphorus 15 mg
  • protect from moisture
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.
Active Ingredient 

Diphenhydramine HCl 25 mg

Inactive Ingredients

Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium phosphate, Magnesium stearate, Microcrystalline cellulose, Phloxine B lake, Polyethylene glycol, Polyvinyl alcohol, Stearic acid, Talc, Titanium dioxide

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 (1-800-222-1222) right away.

Package Label.principal Display Panel

NDC 55681-323-03

Compare to active ingredients of Benadryl ®Allergy Tablets*

ALLERGY RELIEF

DIPHENHYDRAMINE HCl

ANTIHISTAMINE

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl ®Allergy ULTRATAB ®Tablets.

ITEM#PCOTC124

Distributed by:

Twin Med LLC

Santa Fe Springs, CA 90670

www.procureproducts.com

MADE IN THE U.S.A


Structured Label Content

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

     o runny nose

     o sneezing

     o itchy, watery eyes

     o itchy nose or throat

  • temporarily relieves these symptoms of the common cold:

    o runny nose

    o sneezing

Purpose

Antihistamine

Warnings

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

  • trouble urinating due to an enlarged prostate gland
  • glaucoma 
  • a breathing problem such as emphysema or chronic bronchitis

Ask your doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take not more than 6 times in 24 hours
  • adults and children 12 years  and over: 1 or 2 tablets
  • children 6 to under 12 years: 1 tablet
  • children under 6 years: do not use
Questions ?

call toll-free 1-844-912-4012

Other Information
  • each tablet contains:calcium 30 mg
  • each tablet contains:phosphorus 15 mg
  • protect from moisture
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.
Active Ingredient  (Active ingredient )

Diphenhydramine HCl 25 mg

Inactive Ingredients

Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium phosphate, Magnesium stearate, Microcrystalline cellulose, Phloxine B lake, Polyethylene glycol, Polyvinyl alcohol, Stearic acid, Talc, Titanium dioxide

If Pregnant Or Breast Feeding, (If pregnant or 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 (1-800-222-1222) right away.

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

NDC 55681-323-03

Compare to active ingredients of Benadryl ®Allergy Tablets*

ALLERGY RELIEF

DIPHENHYDRAMINE HCl

ANTIHISTAMINE

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl ®Allergy ULTRATAB ®Tablets.

ITEM#PCOTC124

Distributed by:

Twin Med LLC

Santa Fe Springs, CA 90670

www.procureproducts.com

MADE IN THE U.S.A


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)