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Pharbedryl by Pharbest Pharmaceuticals, Inc.

Medically reviewed on June 4, 2018

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: Pharbest Pharmaceuticals, Inc.
NDC Code: 16103-347

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 banded capsule)

Diphenhydramine HCl 50 mg

Purpose

Antihistamine

Uses:
  • Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies:
                    -Sneezing
                    -Nasal congestion
                    -Runny nose
                    -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
  • Trouble urinating due to enlarged prostate gland
  • A breathing problem such as emphysema or chronic bronchitis
  • Glaucoma

Ask doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When using this product
  • Avoid alcoholic drinks
  • Marked drowsiness may occur.
  • Excitability may occur, especially in children
  • Alcohol, sedatives and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions:

  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours.
Adults and children 12 years or over
1 capsule                                     
Children under 12 years
ask a doctor

Other information:
  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • Store at room temperature 15°-30°C (59°-86°F)
  • Protect from moisture
  • Use by expiration date on package

Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate

Questions? Adverse drug event call:

(866) 562-2756

PHARBEDRYL  
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-347
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE  
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE  
SILICON DIOXIDE 
SODIUM LAURYL SULFATE  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize14mm
FlavorImprint CodePH013
Contains    
Packaging
#Item CodePackage Description
1NDC:16103-347-111000 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/11/2006
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIOperations
Pharbest Pharmaceuticals, Inc.557054835manufacture, pack, label

 
Pharbest Pharmaceuticals, Inc.

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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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