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Diphenhist by Rugby Laboratories

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Rugby Laboratories
NDC Code: 0536-1010

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.

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:

  • runny nose 
  • sneezing 
  • itchy, watery eyes
  • 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
  • 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
  • take every 4 to 6 hours 
  • do not take more than 6 doses in 24 hours

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
  • store at controlled room temperature 15°-30°C (59°-86°F) in a dry place
  • protect from moisture
  • contains lactose

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

DIPHENHIST 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1010
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE MONOHYDRATE (ANHYDROUS LACTOSE)  
STARCH, CORN 
Product Characteristics
Colorpink (Half pink and half clear with white powder inside) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeCPC;835
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1010-01100 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/17/2014
Labeler - Rugby Laboratories (079246066)

 
Rugby Laboratories

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Medically reviewed on Aug 29, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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