Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 8975e347-ab18-4c6d-bc36-fb2b889130c3
Route
ORAL
Published
Effective Date 2016-02-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Magnesium Stearate Cellulose, Microcrystalline Titanium Dioxide Polyvinyl Alcohol Polyethylene Glycols Talc D&c Red No. 27

Identifiers & Packaging

Pill Appearance
Imprint: EL Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-01-11

Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg

Uses


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

    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat

  • temporarily relieves these symptoms due to the common cold:

    • runny nose
    • sneezing

Warnings

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 caplets
  • children 6 to under 12 years - 1 caplets
  • children under 6 years - do not use

Do Not Use


  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Other Information


  • each caplet contains; calcium 20 mg
  • store between 20-25 C (68-77 F), Avoid high humidity. Protect from light.

Inactive Ingredients

colloidal silicon dioxide, croscarmallose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, titanium dioxide, d and c red, lecithin, polyvinyl alcohol, polyethylene glycol, talc.

Questions Or Comments?

Call: 1-800-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel

NDC: 70005-001-25

We Care

For Good Health

ALLERGY RELIEF

COMPARE TO THE ACTIVE INGREDIENT IN

Benadryl

CAPSULES

TO OPEN PUSH IN TAB AND PULL OUT

Diphenhydramine HCL, 25 mg

Antihistamine

Relieves:

  • Sneezing
  • Itchy Watery Eyes
  • Runny Nose
  • Itchy Throat

This product is not manufactured or distributed by Johnson and Johnson Consumer Inc., McNeil Consumer Healthcare Division, owner of the registered trademark of Benadryl Capsules.

25 Pouches of 2 Coated Caplets



When Using This Product


  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • be careful when driving a motor vehicle or operating a machinery
  • excitability may occur, especially in children

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

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 You Are

taking sedatives or tranquilizers


Structured Label Content

Uses


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

    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat

  • temporarily relieves these symptoms due to the common cold:

    • runny nose
    • sneezing

Purpose

Antihistamine

Warnings

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 caplets
  • children 6 to under 12 years - 1 caplets
  • children under 6 years - do not use

Do Not Use (Do not use)


  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Other Information


  • each caplet contains; calcium 20 mg
  • store between 20-25 C (68-77 F), Avoid high humidity. Protect from light.

Inactive Ingredients

colloidal silicon dioxide, croscarmallose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, titanium dioxide, d and c red, lecithin, polyvinyl alcohol, polyethylene glycol, talc.

Questions Or Comments? (Questions or comments?)

Call: 1-800-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel

NDC: 70005-001-25

We Care

For Good Health

ALLERGY RELIEF

COMPARE TO THE ACTIVE INGREDIENT IN

Benadryl

CAPSULES

TO OPEN PUSH IN TAB AND PULL OUT

Diphenhydramine HCL, 25 mg

Antihistamine

Relieves:

  • Sneezing
  • Itchy Watery Eyes
  • Runny Nose
  • Itchy Throat

This product is not manufactured or distributed by Johnson and Johnson Consumer Inc., McNeil Consumer Healthcare Division, owner of the registered trademark of Benadryl Capsules.

25 Pouches of 2 Coated Caplets



When Using This Product (When using this product)


  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • be careful when driving a motor vehicle or operating a machinery
  • excitability may occur, especially in children

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

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 right away. (1-800-222-1222)

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (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 You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)