SPL v2
SPL
SPL Set ID 2e7a9032-67d6-d408-e063-6394a90aca8c
Route
ORAL
Published
Effective Date 2025-02-19
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 Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: D25 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01

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 of the 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

  • glaucoma 
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to  enlargement of the prostate gland

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

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and othe tranquilizers may increase drowsiness
  • use caution 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
  • store  at room temperature
  • protct from moisture
  • 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.

Principal Display Panel

NDC 37835-641-01

Compare to the active ingredients in Benadryl ®Allergy ULTRATAB ®Tablets.*

Allergy Medicine

Antihistamine

Diphenhydramine HCl 25 mg

100 Tablets

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

Distributed by:

BI-MART

Eugene, OR 97402

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.

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg


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 of the 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

  • glaucoma 
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to  enlargement of the prostate gland

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

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and othe tranquilizers may increase drowsiness
  • use caution 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
  • store  at room temperature
  • protct from moisture
  • 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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 37835-641-01

Compare to the active ingredients in Benadryl ®Allergy ULTRATAB ®Tablets.*

Allergy Medicine

Antihistamine

Diphenhydramine HCl 25 mg

100 Tablets

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

Distributed by:

BI-MART

Eugene, OR 97402

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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

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