1090 - Qch - 2014-1028

1090 - Qch - 2014-1028
SPL v4
SPL
SPL Set ID e4963eec-fb4a-425c-be19-f514b4f10a7f
Route
ORAL
Published
Effective Date 2014-10-30
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 Calcium Phosphate, Dibasic, Anhydrous Fd&c Yellow No. 6 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Polysorbate 80 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 25;052 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2014-06-13 Until 2026-10-31
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
    • sneezing
    • itchy, watery eyes
    • 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 50568-5

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

Section 50570-1

Do not use 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 exceed 6 doses in 24 hours
adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 tablets)
children 6 to under 12 years of age 12.5 mg
12.5 mg dosage strength is not available in this package. Do not attempt to break tablets.
to 25 mg (1 tablet)
children under 6 years of age ask a doctor
Other Information
  • each tablet contains: calcium 45 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • retain carton for complete product information
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dibasic calcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Principal Display Panel

NDC 63868-492-24

QUALITY CHOICE

†Compare to Active Ingredient in BENADRYL® Allergy

Allergy Relief

Antihistamine

Diphenhydramine HCl, 25 mg

For Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

24 Tablets

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
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

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 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 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

Do not use 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 exceed 6 doses in 24 hours
adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 tablets)
children 6 to under 12 years of age 12.5 mg
12.5 mg dosage strength is not available in this package. Do not attempt to break tablets.
to 25 mg (1 tablet)
children under 6 years of age ask a doctor
Other Information (Other information)
  • each tablet contains: calcium 45 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • retain carton for complete product information
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dibasic calcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 63868-492-24

QUALITY CHOICE

†Compare to Active Ingredient in BENADRYL® Allergy

Allergy Relief

Antihistamine

Diphenhydramine HCl, 25 mg

For Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

24 Tablets

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:46.117934 · Updated: 2026-03-14T23:04:01.123954