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Diphenhist by Rugby Laboratories Inc.

Medically reviewed on December 6, 2017

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Rugby Laboratories Inc.
NDC Code: 0536-3597

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.

Diphenhist

Active Ingredient

(in each captab)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

  • runny nose
  • itchy nose or throat
  • sneezing
  • itchy, watery eyes

WARNINGS

Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & tranquilizers may increase drowsiness
  • be careful 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.

Direction
  • take every 4-6 hours
  • do not take more than 6 doses in 24 hours
    adults and children 12 years and over1 to 2 captabs
    children 6 to under 12 years 1 captab
    children under 6 yearsdo not use

Other Information
  • each captab contains: calcium 45 mg
  • store at room temperature
  • protect from moisture

Inactive Ingredient

croscarmellose sodium, D&C red # 27, dicalcium phosphate,  magnesium stearate, microcrystalline cellulose, opadry clear, titanium dioxide

Questions or Comments

Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Rugby® Duluth, Georgia 30097

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antihistamine

Diphenhydramine HCl 25 mg

NDC 0536-3597-01

100 CAPTABS

Rugby

Duluth, Georgia 30097

DIPHENHIST 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3597
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
TITANIUM DIOXIDE 
HYPROMELLOSES 
POLYETHYLENE GLYCOL 400 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize11mm
FlavorImprint CodeAP;135
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3597-01100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/26/2006
Labeler - Rugby Laboratories Inc. (191427277)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063MANUFACTURE(0536-3597)

 
Rugby Laboratories Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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