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
Purpose

Antihistamine

Description

Drug Facts

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
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
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
  • 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

Description

Drug Facts

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

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.

Questions Or Comments?

1-888-333-9792

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
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
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

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

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.

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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