PHARBEDRYL- diphenhydramine hcl capsule 
Contract Pharmacy Services-PA

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.

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Diphenhydramine 50 mg #30 006
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:

Warnings:


Do not use

Ask a doctor before use if you have

Ask doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

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:

Adults and children 12 years or over
1 capsule                                     
Children under 12 years
ask a doctor

Other information:

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

image of label

PHARBEDRYL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-006(NDC:16103-347)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 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 (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code PH013
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67046-006-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product09/11/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/11/2006
Labeler - Contract Pharmacy Services-PA (945429777)
Establishment
NameAddressID/FEIBusiness Operations
Coupler Enterprises945429777repack(67046-006)

Revised: 9/2017
Document Id: 58ec2343-4c3c-26fa-e053-2a91aa0a4916
Set id: 58ec2343-4c3b-26fa-e053-2a91aa0a4916
Version: 1
Effective Time: 20170911
 
Contract Pharmacy Services-PA