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Pharbedryl by Pharbest Pharmaceuticals, Inc.

Medically reviewed on June 4, 2018

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Pharbest Pharmaceuticals, Inc.
NDC Code: 16103-348

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 25 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 or pharmacist before useIf you have
  • Trouble urinating due to an enlarged prostate gland
  • A breathing problem such as emphysema or chronic bronchitis
  • Glaucoma

Ask a doctor or pharmacist before use of 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 exceed 6 doses in 24 hours.
Adults and children 12 years of age or over
25 mg to 50 mg
(1 to 2 capsules)                                    
Children 6 to under 12 years of age
12.5 mg** to 25 mg (1 capsule)
Children under 6 years
ask a doctor
**12.5 mg dosage strength is not available in this package.
Do not attempt to break capsule.

Other information:
  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • Store at controlled 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

Enter section text here

PHARBEDRYL  
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-348
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 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
Colorpink (PINK (clear) , WHITE (clear) , RED (band) ) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint CodePH014
Contains    
Packaging
#Item CodePackage Description
1NDC:16103-348-031 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
124 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC
2NDC:16103-348-081 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
2100 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC
3NDC:16103-348-111000 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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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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