Amerisource Bergen Allergy Drug Facts

Amerisource Bergen Allergy Drug Facts
SPL v7
SPL
SPL Set ID 9819522f-f3db-4cb8-9680-423114ace2f6
Route
ORAL
Published
Effective Date 2023-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Carnauba Wax Crospovidone (120 .mu.m) D&c Red No. 27 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Stearic Acid Titanium Dioxide Dibasic Calcium Phosphate Dihydrate

Identifiers & Packaging

Pill Appearance
Imprint: L479 Shape: oval Color: pink Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 1991-08-30 Until 2018-11-27
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
  • •
    sneezing
  • •
    itchy, watery eyes
  • •
    itchy nose or throat
  • •
    temporarily relieves these symptoms of the common cold:
  • •
    runny nose
  • •
    sneezing
Directions
  • •
    take every 4 to 6 hours, or as directed by a doctor
  • •
    do not take more than 6 doses 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
  • •
    with any other product containing diphenhydramine, even one used on skin
  • •
    to make a child sleepy
Other Information
  • •
    each tablet contains: calcium 20 mg
  • •
    store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
Inactive Ingredients

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments?

1-800-719-9260

Principal Display Panel

Good Neighbor Pharmacy®

Compare to Benadryl® Allergy Ultratab® Tablets active ingredient

Allergy diphenhydramine HCl

SMALL TABLET SIZE

Antihistamine

● Sneezing ● Itchy, Watery Eyes ● Runny Nose ● Itchy Throat

actual size

100 Tablets | 25 mg Each

When Using This Product
  • •
    marked drowsiness may occur
  • •
    avoid alcoholic drinks
  • •
    excitability may occur, especially in children
  • •
    alcohol, sedatives and tranquilizers may increase drowsiness
  • •
    be careful when driving a motor vehicle or operating machinery
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 (1-800-222-1222).

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have
  • •
    glaucoma
  • •
    trouble urinating due to an enlarged prostate gland
  • •
    a breathing problem such as emphysema or chronic bronchitis
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
  • •
    sneezing
  • •
    itchy, watery eyes
  • •
    itchy nose or throat
  • •
    temporarily relieves these symptoms of the common cold:
  • •
    runny nose
  • •
    sneezing
Purpose

Antihistamine

Directions
  • •
    take every 4 to 6 hours, or as directed by a doctor
  • •
    do not take more than 6 doses 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)
  • •
    with any other product containing diphenhydramine, even one used on skin
  • •
    to make a child sleepy
Other Information (Other information)
  • •
    each tablet contains: calcium 20 mg
  • •
    store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
Inactive Ingredients (Inactive ingredients)

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Principal Display Panel

Good Neighbor Pharmacy®

Compare to Benadryl® Allergy Ultratab® Tablets active ingredient

Allergy diphenhydramine HCl

SMALL TABLET SIZE

Antihistamine

● Sneezing ● Itchy, Watery Eyes ● Runny Nose ● Itchy Throat

actual size

100 Tablets | 25 mg Each

When Using This Product (When using this product)
  • •
    marked drowsiness may occur
  • •
    avoid alcoholic drinks
  • •
    excitability may occur, especially in children
  • •
    alcohol, sedatives and tranquilizers may increase drowsiness
  • •
    be careful when driving a motor vehicle or operating machinery
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 (1-800-222-1222).

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)
  • •
    glaucoma
  • •
    trouble urinating due to an enlarged prostate gland
  • •
    a breathing problem such as emphysema or chronic bronchitis
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

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:18.918528 · Updated: 2026-03-14T23:03:20.235753