SPL v1
SPL
SPL Set ID ff8b096c-8f01-4a8c-a98f-e4aa4d688e95
Route
ORAL
Published
Effective Date 2025-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Microcrystalline Cellulose Povidone K30 Silicon Dioxide Croscarmellose Sodium Magnesium Stearate Polyvinyl Alcohol Polyethylene Glycol, Unspecified Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Talc Titanium Dioxide D&c Red No. 28

Identifiers & Packaging

Pill Appearance
Imprint: N02 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-04
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.

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 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 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: 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 avicel 102,polyvinylpyrrolidone, colloidal silicone dioxide, Croscarmellose Sodium,  Magnesium Stearate, purified water, readycoat pink contains: polyvinlyalcohol, polyethylene glycol, methacrylic acid copolymer, talc, fumed silica, titanium dioxide, Phloxine b lake.

Questions Or Comments?

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

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25mg

Ndc 720090 040 02 (600s Count Bottle)

Ndc 720090 040 01 (1000s Count Bottle)

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.

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 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 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: 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 avicel 102,polyvinylpyrrolidone, colloidal silicone dioxide, Croscarmellose Sodium,  Magnesium Stearate, purified water, readycoat pink contains: polyvinlyalcohol, polyethylene glycol, methacrylic acid copolymer, talc, fumed silica, titanium dioxide, Phloxine b lake.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

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

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

Diphenhydramine HCl 25mg

Ndc 720090 040 02 (600s Count Bottle) (NDC 720090-040-02 (600s count Bottle))

Ndc 720090 040 01 (1000s Count Bottle) (NDC 720090-040-01 (1000s count Bottle))

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:40.762760 · Updated: 2026-03-14T23:07:51.764628