DIPHENHIST- diphenhydramine hcl capsule 
Rugby Laboratories

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0835-Rugby

Drug Facts

Active ingredient (in each banded capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

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
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if

you are taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when operating machinery or driving a motor vehicle
  • excitability may occur, especially in children

If pregnant of 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

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

Directions

adults and children 12 years of age and over

1 to 2 capsules

children 6 to under 12 years of age

1 capsule

children under 6 years of age

do not use this product in children under 6 years of age

Other information

Inactive ingredients

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch.

Questions or comments?

1-800-645-2158

DO NOT USE IF EITHER CAPSULE BAND OR IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

www.rugbylaboratories.com

Rugby

NDC 0536-1010-01

Diphenhist

Diphenhydramine HCl USP, 25 mg

Antihistamine

For the temporary relief of the Symptoms of Upper Respiratory Allergies & Hay Fever

100 Banded Capsules

0835-rugby label

DIPHENHIST 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1010
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. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
Colorpink (Half pink and half clear with white powder inside) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;835
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1010-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/17/201404/30/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/17/201404/30/2025
Labeler - Rugby Laboratories (079246066)

Revised: 1/2024
Document Id: 0eaf12c0-ca13-1396-e063-6294a90aa5c8
Set id: f7da0c1b-b471-48ee-99c7-e957eae31b9c
Version: 5
Effective Time: 20240111
 
Rugby Laboratories