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Diphenhist by Rugby Laboratories

Medically reviewed on Aug 27, 2018

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.

DRUG FACTS

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of the common cold:

  • runny nose
  • sneezing 

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

  • runny nose
  • sneezing
  • itching of the nose or throat
  • 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
  • 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
  • excitability may occur, especially in children
  • marked drowsiness may occur

  • avoid alcoholic drinks

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • be careful when operating machinery or driving a motor vehicle

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

Directions
  • take every 4 to 6 hours, not more than 6 doses in 24 hours
  adults and children 12 years of age and over  take 1 to 2 capsules 
  children 6 to under 12 years of age  take 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

  • do not use if imprinted safety seal under cap is broken or missing
  • do not use if red band around capsule is broken or missing

Inactive ingredients

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

Questions or comments?

Call toll free 1-800-645-2158

Principal Display Panel

Diphenhist Capsules

Antihistamine

For the temporary relief of:

sneezing, itchy & watery eyes, runny nose & itchy throat

Diphenhydramine HCl 25 mg

Product Label
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 
STARCH, CORN 
Product Characteristics
ColorPINK (and white) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeCPC835
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 FINALpart33603/17/2014
Labeler - Rugby Laboratories (079246066)

 
Rugby Laboratories

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Further information

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

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