American Sales Company Allergy Relief Drug Facts

American Sales Company Allergy Relief Drug Facts
SPL v5
SPL
SPL Set ID ed4038fc-ab39-4567-9961-2b390b91b126
Route
ORAL
Published
Effective Date 2020-02-06
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;25 Shape: oval Color: pink Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-09-21 Until 2024-12-31
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
  • •
    sneezing
  • •
    itchy, watery eyes
  • •
    itching of the 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

Compare to active ingredient in Benadryl® Allergy Ultratabs®

Easy To Swallow

Allergy Relief

Diphenhydramine Hydrochloride Tablets, 25 mg Antihistamine

Actual Size

100 TABLETS

FOR ALLERGY RELIEF OF:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat

Gluten Free

When Using This Product
  • •
    marked drowsiness may occur
  • •
    avoid alcoholic drinks
  • •
    alcohol, sedatives, and tranquilizers may increase drowsiness
  • •
    be careful 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 (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
  • •
    itching of the 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

Compare to active ingredient in Benadryl® Allergy Ultratabs®

Easy To Swallow

Allergy Relief

Diphenhydramine Hydrochloride Tablets, 25 mg Antihistamine

Actual Size

100 TABLETS

FOR ALLERGY RELIEF OF:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat

Gluten Free

When Using This Product (When using this product)
  • •
    marked drowsiness may occur
  • •
    avoid alcoholic drinks
  • •
    alcohol, sedatives, and tranquilizers may increase drowsiness
  • •
    be careful 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 (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

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Source: dailymed · Ingested: 2026-02-15T12:03:18.856350 · Updated: 2026-03-14T23:03:18.838207