Premier Value 44-190 Delisted

Premier Value 44-190 Delisted
SPL v14
SPL
SPL Set ID 26f0aa83-2191-410e-9d0d-9ff5186a8a88
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
Butylparaben Starch, Corn D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Anhydrous Lactose Magnesium Stearate Methylparaben Polysorbate 80 Propylparaben Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;107 Shape: capsule Color: pink Color: white Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 1990-03-15 Until 2026-03-31

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
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over 1 to 2 capsules
children 6 to under 12 years 1 capsule
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
  • 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

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

Questions Or Comments?

1-800-426-9391

Principal Display Panel

Premier

Value®

*COMPARE TO THE ACTIVE INGREDIENT

IN BENADRYL®

Allergy Relief

Diphenhydramine HCl, 25 mg

ANTIHISTAMINE

Allergy relief for: 

• sneezing  

• runny nose

• itchy, watery eyes 

• itchy throat

actual size

100 Capsules

PV

INDEPENDENTLY TESTED

SATISFACTION GUARANTEED

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL

UNDER CAP IS BROKEN OR MISSING OR IF RED BAND

AROUND CAPSULE IS BROKEN OR MISSING

*This product is not manufactured or distributed

by Johnson & Johnson Corporation, owner of the

registered trademark Benadryl®.

50844           REV1117B19012

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 44-190
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.

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


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
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over 1 to 2 capsules
children 6 to under 12 years 1 capsule
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)
  • 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)

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

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

Premier

Value®

*COMPARE TO THE ACTIVE INGREDIENT

IN BENADRYL®

Allergy Relief

Diphenhydramine HCl, 25 mg

ANTIHISTAMINE

Allergy relief for: 

• sneezing  

• runny nose

• itchy, watery eyes 

• itchy throat

actual size

100 Capsules

PV

INDEPENDENTLY TESTED

SATISFACTION GUARANTEED

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL

UNDER CAP IS BROKEN OR MISSING OR IF RED BAND

AROUND CAPSULE IS BROKEN OR MISSING

*This product is not manufactured or distributed

by Johnson & Johnson Corporation, owner of the

registered trademark Benadryl®.

50844           REV1117B19012

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 44-190
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.

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
  • difficulty in urination due to enlargement of the 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.


Advanced Ingredient Data


Raw Label Data

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