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
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
  • •
    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
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

Description

Diphenhydramine HCl 25 mg

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

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

1-800-719-9260

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).

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

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
  • •
    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
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

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

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

1-800-719-9260

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).

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