Diphenhydramine 25mg Tabs

Diphenhydramine 25mg Tabs
SPL v1
SPL
SPL Set ID bc7fe079-403d-1000-e053-2995a90a235f
Route
ORAL
Published
Effective Date 2021-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Starch, Corn D&c Red No. 27 Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Stearic Acid Talc Titanium Dioxide Anhydrous Dibasic Calcium Phosphate

Identifiers & Packaging

Pill Appearance
Imprint: 44;329 Shape: oval Color: pink Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-03-28

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

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 to under 12 years 1 tablet
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 tablet contains: calcium 30 mg

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture

  • use by expiration date on package

Inactive Ingredients

corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments?

(800) 645-2158

Principal Display Panel

Rugby ®

NDC 0536-1214-29

COMPARE TO THE

ACTIVE INGREDIENT IN

BENADRYL ®

ALLERGY ULTRATAB ® TABLETS*

Diphenhydramine HCl, 25 mg

Antihistamine 

Allergy Relief

Relieves Sneezing,

Runny Nose, Itchy throat

& Itchy, Watery Eyes

100 TABLETS

Actual Size

Easy to Swallow

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Johnson & Johnson Corporation,

owner of the registered trademark Benadryl® Allergy ULTRATAB® Tablets.

50844    ORG101632912

Distributed by: Rugby Laboratories, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152

www.rugbylaboratories.com

Rev.02/19 R-17  Re-order No. 370672

When Using This Product
  • marked drowsiness may occur

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating 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 (1-800-222-1222) right away

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

  • difficulty in urination due to enlargement of the prostate gland

Package Label.principal Display Panel

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

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 to under 12 years 1 tablet
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 (Other information)
  • each tablet contains: calcium 30 mg

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture

  • use by expiration date on package

Inactive Ingredients (Inactive ingredients)

corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

(800) 645-2158

Principal Display Panel (Principal display panel)

Rugby ®

NDC 0536-1214-29

COMPARE TO THE

ACTIVE INGREDIENT IN

BENADRYL ®

ALLERGY ULTRATAB ® TABLETS*

Diphenhydramine HCl, 25 mg

Antihistamine 

Allergy Relief

Relieves Sneezing,

Runny Nose, Itchy throat

& Itchy, Watery Eyes

100 TABLETS

Actual Size

Easy to Swallow

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Johnson & Johnson Corporation,

owner of the registered trademark Benadryl® Allergy ULTRATAB® Tablets.

50844    ORG101632912

Distributed by: Rugby Laboratories, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152

www.rugbylaboratories.com

Rev.02/19 R-17  Re-order No. 370672

When Using This Product (When using this product)
  • marked drowsiness may occur

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating 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 (1-800-222-1222) right away

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

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

  • difficulty in urination due to enlargement of the prostate gland

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

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)