Premier Value 44-329 Delisted

Premier Value 44-329 Delisted
SPL v14
SPL
SPL Set ID f8204fe6-3b34-4212-a925-5f7a5090e0d7
Route
ORAL
Published
Effective Date 2025-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Starch, Corn D&c Red No. 27 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;329 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 1990-03-02 Until 2026-05-31

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
    • itchy, watery eyes
    • sneezing

    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Directions
  • do not take more than directed
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and over 1 to 2 tablets
children 6 to under 12 years

1 tablet

children under 6 years

do not use
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin 
Other Information
  • each tablet contains: calcium 30 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-426-9391 

Principal Display Panel

Premier

Value®

*COMPARE TO THE ACTIVE INGREDIENT

IN BENADRYL® ALLERGY ULTRATAB® TABLETS

Complete Allergy

Diphenhydramine HCl, 25 mg

ANTIHISTAMINE

Allergy relief for:

• Sneezing                  • Runny nose

• Itchy, watery eyes    • Itchy throat

actual

size

24 Tablets

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the

registered trademark Benadryl® Allergy ULTRATAB® Tablets.   50844    REV0721C32908

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087


If for any reason you are not satisfied with

this product, please return it to the store

where purchased for a full refund.

Premier Value 44-329

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic beverages

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution 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. 

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers. 


Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing

    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Purpose

Antihistamine

Directions
  • do not take more than directed
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and over 1 to 2 tablets
children 6 to under 12 years

1 tablet

children under 6 years

do not use
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)
  • each tablet contains: calcium 30 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391 

Principal Display Panel

Premier

Value®

*COMPARE TO THE ACTIVE INGREDIENT

IN BENADRYL® ALLERGY ULTRATAB® TABLETS

Complete Allergy

Diphenhydramine HCl, 25 mg

ANTIHISTAMINE

Allergy relief for:

• Sneezing                  • Runny nose

• Itchy, watery eyes    • Itchy throat

actual

size

24 Tablets

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the

registered trademark Benadryl® Allergy ULTRATAB® Tablets.   50844    REV0721C32908

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087


If for any reason you are not satisfied with

this product, please return it to the store

where purchased for a full refund.

Premier Value 44-329

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic beverages

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children 
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 right away. 

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

Diphenhydramine HCl 25 mg

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
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers. 


Advanced Ingredient Data


Raw Label Data

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