allergy relief

allergy relief
SPL v15
SPL
SPL Set ID 69af44c2-390c-4223-889a-d5555aef5778
Route
oral
Published
Effective Date 2025-06-11
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 1990-03-02 Until 2021-02-15
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
    • itching of the nose or throat
    • sneezing
  • 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
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
  • protect from moisture
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

Since 1903

Rexall®

Allergy Relief

Diphenhydramine HCl, 25 mg

Antihistamine

Relief of

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy throat

Actual

Size

365

Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

50844 REV0721D32951

Visit us at: Rexall.com or call 1-866-4-REXALL

MANUFACTURED FOR OLD EAST MAIN CO.

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 USA

Rexall 44-329
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
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
    • itching of the nose or throat
    • sneezing
  • 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
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
  • protect from moisture
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

Since 1903

Rexall®

Allergy Relief

Diphenhydramine HCl, 25 mg

Antihistamine

Relief of

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy throat

Actual

Size

365

Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS BROKEN OR MISSING

50844 REV0721D32951

Visit us at: Rexall.com or call 1-866-4-REXALL

MANUFACTURED FOR OLD EAST MAIN CO.

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 USA

Rexall 44-329
Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:17.928833 · Updated: 2026-03-14T23:08:59.288880