Gencare-allergy Relief diphenhydramine Hcl 25mg Softgel

Gencare-allergy Relief diphenhydramine Hcl 25mg Softgel
SPL v1
SPL
SPL Set ID bb9a82b1-ea7a-4d10-bc00-05013e83c4d3
Route
ORAL
Published
Effective Date 2025-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Polyethylene Glycol 400 Propylene Glycol Gelatin Glycerin Sorbitol Solution Sorbitan Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-30

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: ■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 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50567-7

When using this product 

■ 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 51945-4

Section 53414-9

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

Warnings

Do not use:

■ to make a child sleepy

■ with any other product containing diphenhydramine, even one used on skin.

Directions:

■ Take every 4 to 6 hours, or as directed by a doctor

■ Do not take more than 6 doses in 24 hours.

■ Adults and children 12 years and over: 1 to 2 softgels

■ Children 6 years to under 12 years: 1 softgel

■ Children under 6 years: Do not use

Other Information:

■ Store between 20º-25ºC (68º-77ºF). Avoid high humidity. Protect from moisture and light.

Inactive Ingredients:

Polyethylene Glycol 400, Propylene Glycol, Gelatin, Glycerin, Sorbitol Sorbitan Solution, Purified Water

Questions Or Comments?

Call +1 (732) 994-2808 or email [email protected]

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25mg

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 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50567-7 (50567-7)

When using this product 

■ 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 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Purpose

Antihistamine

Warnings

Do not use:

■ to make a child sleepy

■ with any other product containing diphenhydramine, even one used on skin.

Directions:

■ Take every 4 to 6 hours, or as directed by a doctor

■ Do not take more than 6 doses in 24 hours.

■ Adults and children 12 years and over: 1 to 2 softgels

■ Children 6 years to under 12 years: 1 softgel

■ Children under 6 years: Do not use

Other Information:

■ Store between 20º-25ºC (68º-77ºF). Avoid high humidity. Protect from moisture and light.

Inactive Ingredients:

Polyethylene Glycol 400, Propylene Glycol, Gelatin, Glycerin, Sorbitol Sorbitan Solution, Purified Water

Questions Or Comments?

Call +1 (732) 994-2808 or email [email protected]

Active Ingredient (in Each Softgel) (Active Ingredient (In Each Softgel))

Diphenhydramine HCl 25mg

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

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