Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

PHARBEDRYL  - diphenhydramine hcl capsule 
A-S Medication Solutions

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 use

If you haveTrouble urinating due to an enlarged prostate glandA breathing problem such as emphysema or chronic bronchitisGlaucoma

Ask a doctor or pharmacist before use of you are

taking 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 hoursDo not exceed 6 doses in 24 hours.Adults and children 12 years of age or over25 mg to 50 mg (1 to 2 capsules)                                     Children 6 to under 12 years of age12.5 mg** to 25 mg (1 capsule)Children under 6 yearsask 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

HOW SUPPLIED

Product: 50090-1639

Diphenhydramine HCl

Label Image
PHARBEDRYL  
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50090-1639(NDC: 16103-348)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
Colorpink (PINK (clear) , WHITE (clear) , RED (band) ) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code PH014
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50090-1639-110 in 1 BOTTLE; Type 0: Not a Combination Product01/15/201506/30/2019
2NDC: 50090-1639-08 in 1 BOTTLE; Type 0: Not a Combination Product01/15/201506/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/11/200606/30/2019
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-1639) , REPACK(50090-1639)

Revised: 1/2020