Allergy Relief

Allergy Relief
SPL v7
SPL
SPL Set ID 2f4071dd-9898-4fa2-9b9f-148d45b9dcdb
Route
ORAL
Published
Effective Date 2020-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium D&c Red No. 27 Anhydrous Dibasic Calcium Phosphate Lecithin, Soybean Magnesium Stearate Cellulose, Microcrystalline Polyvinyl Alcohol, Unspecified Polyethylene Glycol, Unspecified Talc Titanium Dioxide Water

Identifiers & Packaging

Pill Appearance
Imprint: S4 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-13
Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7

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
Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
Section 50570-1

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years of age and over 1 to 2 tablets
children 6 to under 12 years of age 1 tablet
children under 6 years of age do not use this product in children under 6 years of age
Other Information
  • store at controlled room temperature 15°-30° C (59°-86° F)
  • protect from moisture and light
  • see end flap for expiration date and lot number
  • each tablet contains calcium 24 mg
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C red # 27 Al lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT OF

BENADRYL ® ALLERGY ULTRATAB ®*

Allergy

Diphenhydramine HCl 25 mg

Antihistamine

Sneezing, Runny Nose, Itchy Throat,

Itchy, Watery Eyes

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

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
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
Section 50570-1 (50570-1)

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antihistamine

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years of age and over 1 to 2 tablets
children 6 to under 12 years of age 1 tablet
children under 6 years of age do not use this product in children under 6 years of age
Other Information (Other information)
  • store at controlled room temperature 15°-30° C (59°-86° F)
  • protect from moisture and light
  • see end flap for expiration date and lot number
  • each tablet contains calcium 24 mg
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C red # 27 Al lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO ACTIVE INGREDIENT OF

BENADRYL ® ALLERGY ULTRATAB ®*

Allergy

Diphenhydramine HCl 25 mg

Antihistamine

Sneezing, Runny Nose, Itchy Throat,

Itchy, Watery Eyes

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:57.131487 · Updated: 2026-03-14T23:06:08.994677