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 50mg

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.

Directions

Adults and children 12 years of age & over

1 capsule

Children under 12 years of age

Ask a doctor

Other information

Tamper Evident:

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 16103-0347-08

Manufactured in the USA

PHARBEDRYL

Diphenhydramine HCl 50mg

Antihistamine

• Sneezing • Runny Nose

• Itchy, Watery Eyes • Itchy Throat

1000 CAPSULES

Pharbedryl 50mg capsule Product Label

PHARBEDRYL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:16103-347-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/2006
2NDC:16103-347-08100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/11/2006
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835analysis(16103-347) , manufacture(16103-347) , pack(16103-347) , label(16103-347)

Revised: 1/2021
Document Id: 9f7c06ed-c63f-4e18-91e7-7436366cc850
Set id: a19f1edc-d2cf-45fc-8233-d882441b0247
Version: 2
Effective Time: 20210111
 
Pharbest Pharmaceuticals, Inc.