SPL v3
SPL
SPL Set ID a7999da7-148a-4c6d-a2ea-0f4cc1d5b283
Route
ORAL
Published
Effective Date 2024-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Cellulose, Microcrystalline Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Silicon Dioxide Magnesium Stearate Talc Titanium Dioxide Polyethylene Glycol, Unspecified Fd&c Red No. 3 Hypromellose, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: I3 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-25

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 42229-5

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark BENADRYL® Tablets.

Distributed by: GenCare Consumer Products, LLC

40E Cotters Ln, Suite A, East Brunswick, New Jersey 08816

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 50569-3

Ask a doctor before use if you have

  • glaucoma
  • troble urinating due to an enlarged prostate gland 
  • a breathing problem such as emphysema or chronic bronchitis
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 times in 24 hours.

■Adults and children 12 years and over: Take 1 to 2 tablets

■ Children 6 years to under 12 years: 1 tablet

■Children under 6 years: Do not use 

Other Information

Each tablet contains: ■ Calcium 24mg ■Store between 20º-25ºC (68º-77ºF). Avoid high humidity. Protect from moisture and light.

Inactive Ingredients

Microcrystalline Cellulose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Magnesium Stearate, Hydroxy Propyl Methyl Cellulose, Polyethylene Glycol, Titanium Dioxide, Talc, FD&C Red#3.

Questions Or Comments?

Call 1-732-698-5070 Monday through Friday 9 AM to 5 PM EST 

Keep Out of Reach of Children

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.

Active Ingredient (in Each Tablet)

Diphenhydramine Hcl 25mg


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)

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark BENADRYL® Tablets.

Distributed by: GenCare Consumer Products, LLC

40E Cotters Ln, Suite A, East Brunswick, New Jersey 08816

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 50569-3 (50569-3)

Ask a doctor before use if you have

  • glaucoma
  • troble urinating due to an enlarged prostate gland 
  • a breathing problem such as emphysema or chronic bronchitis
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 (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 and over: Take 1 to 2 tablets

■ Children 6 years to under 12 years: 1 tablet

■Children under 6 years: Do not use 

Other Information (OTHER INFORMATION)

Each tablet contains: ■ Calcium 24mg ■Store between 20º-25ºC (68º-77ºF). Avoid high humidity. Protect from moisture and light.

Inactive Ingredients (INACTIVE INGREDIENTS)

Microcrystalline Cellulose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Magnesium Stearate, Hydroxy Propyl Methyl Cellulose, Polyethylene Glycol, Titanium Dioxide, Talc, FD&C Red#3.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-732-698-5070 Monday through Friday 9 AM to 5 PM EST 

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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.

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

Diphenhydramine Hcl 25mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)