ff8b096c-8f01-4a8c-a98f-e4aa4d688e95

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

Purpose

Antihistamine

Description

Diphenhydramine HCl 25mg


Medication Information

Active Ingredient

Diphenhydramine HCl 25mg

Purpose

Antihistamine

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.

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
Questions Or Comments?

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

Ndc 720090 040 02 (600s Count Bottle)

Ndc 720090 040 01 (1000s Count Bottle)


Structured Label Content

Active Ingredient (Active Ingredient (in each tablet))

Diphenhydramine HCl 25mg

Purpose

Antihistamine

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.

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.

Warnings:

DO NOT USE:

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments? (QUESTIONS OR COMMENTS?)

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

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

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