DIPHENHYDRAMINE HCL tablet, coated

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

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

Do not use

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

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
  

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

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

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 yearsand over: 1 to 2 tablets
• children 6 to under 12 years: 1 tablet
• children under 6 years: do not use

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

Rugby 44-329

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 
diphenhydramine hcl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1214
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	44;329
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1214-29	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/28/2019

Labeler - Rugby Laboratories (079246066)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(0536-1214)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	MANUFACTURE(0536-1214) , PACK(0536-1214)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(0536-1214)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0536-1214)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(0536-1214)