DIPHENHYDRAMINE HCL- diphenhydramine hcl tablet, film coated 
Rugby Laboratories

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Rugby 44-329

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 right away.

Directions

adults and children 12 years and over1 to 2 tablets
children 6 to under 12 years
1 tablet
children under 6 years
do not use

Other information

Inactive ingredients

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

Questions or comments?

1-800-645-2158

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
and Itchy, Watery Eyes

100 Tablets
Actual Size

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    REV0721B32912

Distributed by: RUGBY® LABORATORIES
Livonia, MI 48152
www.rugbylaboratories.com

Rev.09/21
R-17 
Re-order No. 370672

Rugby 44-329 REV0721B

Rugby 44-329 REV0721B

DIPHENHYDRAMINE HCL 
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
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)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize11mm
FlavorImprint Code 44;329
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1214-29100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/28/2019
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(0536-1214)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(0536-1214) , pack(0536-1214)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(0536-1214)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(0536-1214)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(0536-1214)

Revised: 10/2023
Document Id: e087f0f2-d5f5-4751-9913-dfa4aab1c547
Set id: 6c4f280d-9a98-40c3-a459-4220cf34c313
Version: 9
Effective Time: 20231021
 
Rugby Laboratories