DIPHENHYDRAMINE HCL- diphenhydramine hcl tablet, coated 
RedPharm Drug, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Diphenhydramine 25mg tabs

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

adults and children 12 years
and over
1 to 2 tablets
children 6 to under 12 years1 tablet
children under 6 yearsdo not use

Other information

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

24 COUNT LABEL

DIPHENHYDRAMINE HCL 
diphenhydramine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67296-1426(NDC:0536-1214)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScoreno score
ShapeOVALSize11mm
FlavorImprint Code 44;329
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67296-1426-724 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/28/2019
Labeler - RedPharm Drug, Inc. (828374897)
Establishment
NameAddressID/FEIBusiness Operations
EPM Packaging, Inc.079124340repack(67296-1426) , label(67296-1426)

Revised: 3/2021
Document Id: bc7fdd23-6917-1cbd-e053-2a95a90a85b6
Set id: bc7fe079-403d-1000-e053-2995a90a235f
Version: 1
Effective Time: 20210301
 
RedPharm Drug, Inc.