Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID f3b177ef-55d5-4525-bf33-99205c414a5b
Route
ORAL
Published
Effective Date 2023-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Red No. 27 Aluminum Lake Hypromellose, Unspecified Lactose, Unspecified Form Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Silicon Dioxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 048;D Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2016-04-28 Until 2026-12-01

Description

 Diphenhydramine HCl 25mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

 Diphenhydramine HCl 25mg

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

Sneezing, runny nose, itchy / watery eyes, and itching of the nose or throat

Temporarily relieves these symptoms associated with the common cold:

Sneezing, runny nose

Section 51945-4
Warnings

Do not usewith any other products containing diphenhydramine, including ones used on skin

Ask a doctor before use if you have:

A breathing problem such as emphysema or chronic bronchitis

Glaucoma

Trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if youare taking sedatives or tranquilizers

When using this product:

Marked drowsiness may occur

Avoid alcoholic beverages

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

Directions

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 of age and older: 1 to 2 caplets

Children 6 to 12 years:1 caplet

Children under 6:do not use

Active Ingredient

 Diphenhydramine HCl 25mg

Inactive Ingredients

croscarmellose sodium, D C Red 27 aluminum lake, hypromellose, lactose, magnesium stearate, microcystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.


Structured Label Content

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

Sneezing, runny nose, itchy / watery eyes, and itching of the nose or throat

Temporarily relieves these symptoms associated with the common cold:

Sneezing, runny nose

Section 51945-4 (51945-4)
Purpose

Antihistamine

Warnings

Do not usewith any other products containing diphenhydramine, including ones used on skin

Ask a doctor before use if you have:

A breathing problem such as emphysema or chronic bronchitis

Glaucoma

Trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if youare taking sedatives or tranquilizers

When using this product:

Marked drowsiness may occur

Avoid alcoholic beverages

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

Directions

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 of age and older: 1 to 2 caplets

Children 6 to 12 years:1 caplet

Children under 6:do not use

Active Ingredient

 Diphenhydramine HCl 25mg

Inactive Ingredients

croscarmellose sodium, D C Red 27 aluminum lake, hypromellose, lactose, magnesium stearate, microcystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.


Advanced Ingredient Data


Raw Label Data

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