7b000478-649d-4511-b3e0-eea6995b9784

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

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg


Medication Information

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
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

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
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.
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

Description

Diphenhydramine HCl 25 mg

Questions ?

call toll-free 1-844-912-4012

Active Ingredient 

Diphenhydramine HCl 25 mg

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

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
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

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
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.
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

Questions ?

call toll-free 1-844-912-4012

Active Ingredient  (Active ingredient )

Diphenhydramine HCl 25 mg

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


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Raw Label Data

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