PHARBEDRYL - diphenhydramine hcl capsule 
Pharbest Pharmaceuticals, Inc.

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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Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25mg

Purpose

Antihistamine

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a 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 overdose, get medical help or contact a Poison Control Center right away 91-800-222-1222).

Directions

adults and children 12 years and above1-2 capsules       
children 6 to under 12 years 1 capsule
children under 6 yearsAsk a doctor

Other information

Inactive ingredients

black iron oxide, D&C red #28, D&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 Mon - Fri 8 AM to 4 PM

PHARBEST

NDC 16103-0348-11

Manufactured in the USA

* Compare to the active ingredient in Benadryl® Ultratabs

PHARBEDRYL

Diphenhydramine HCl 25mg

Antihistamine

• Sneezing                    • Runny Nose

• Itchy, Watery Eyes      • Itchy Throat

1000 CAPSULES

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

Pharbedryl 25mg capsule Product Label

PHARBEDRYL  
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:16103-348-031 in 1 CARTON02/01/2016
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:16103-348-081 in 1 CARTON02/01/2016
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:16103-348-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/01/2016
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835analysis(16103-348) , manufacture(16103-348) , pack(16103-348) , label(16103-348)

Revised: 6/2023
Document Id: 597998c7-96d5-496b-8fcd-e9677dc15b34
Set id: 070e556b-e083-452f-8a7c-aca92470dd61
Version: 3
Effective Time: 20230613
 
Pharbest Pharmaceuticals, Inc.