members mark 44-329 aller-ben

members mark 44-329 aller-ben
SPL v8
SPL
SPL Set ID 55d4f1c3-a97b-4b33-a392-7cab00b56de5
Route
oral
Published
Effective Date 2025-07-09
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 active Since 2020-02-18

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg


Medication Information

Active Ingredient

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
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
Other Information
  • each tablet contains: calcium 30 mg
  • protect from moisture
  • use by expiration date on package
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
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

Description

Diphenhydramine HCl 25 mg

Principal Display Panel

Compare to Benadryl® Allergy

Ultratab® active ingredient*


NDC 68196-829-78

Member's Mark™

Aller-Ben™

Diphenhydramine HCl 25 mg

Antihistamine

Allergy

For Allergy Relief of

• Sneezing • Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

actual

size

600

Tablets


TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


Comments or Questions?

Call 1-800-426-9391

from 8:30a.m. to 4:00p.m. ET

Monday-Friday

*This product is not manufactured or distributed by Johnson

& Johnson Corporation, owner of the registered trademark

Benadryl® Allergy Ultratab®.    50844    REV0721B32978

DISTRIBUTED BY: SAM'S WEST, INC.,

BENTONVILLE, AR 72716

Members Mark 44-329
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments?

1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

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
  • 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 Are

taking sedatives or tranquilizers.


Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

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
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
Other Information (Other information)
  • each tablet contains: calcium 30 mg
  • protect from moisture
  • use by expiration date on package
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
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

Principal Display Panel (Principal display panel)

Compare to Benadryl® Allergy

Ultratab® active ingredient*


NDC 68196-829-78

Member's Mark™

Aller-Ben™

Diphenhydramine HCl 25 mg

Antihistamine

Allergy

For Allergy Relief of

• Sneezing • Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

actual

size

600

Tablets


TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


Comments or Questions?

Call 1-800-426-9391

from 8:30a.m. to 4:00p.m. ET

Monday-Friday

*This product is not manufactured or distributed by Johnson

& Johnson Corporation, owner of the registered trademark

Benadryl® Allergy Ultratab®.    50844    REV0721B32978

DISTRIBUTED BY: SAM'S WEST, INC.,

BENTONVILLE, AR 72716

Members Mark 44-329
Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments? (Questions or comments?)

1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

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)
  • 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 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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