ALLERGY RELIEF DIPHENHYDRAMINE HCL 50 MG- diphenhydramine hcl capsule 
YYBA Corporation

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 banded capsule)

Diphenhydramine HCL 50 mg

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 (1-800-222-1222)

Directions:

adults and children 12 years and over1 capsule                                     
children under 12 yearsask 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 or comments?

(866) 933-6337 (Mon-Fri 8 AM to 4 PM EST)

welmate

Compare to active ingredient in BENADRYL® Allergy Extra Strength*

ANTIHISTAMINE

Allergy Relief

Diphenhydramine

HCl Capsules, USP 50 mg

For temporary relief of:

Sneezing

Runny nose

Itchy watery eyes

Itchy nose or throat

1000 CAPSULES

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

welmate Allergy Relief Capsule 50 mg 1000 ct.

ALLERGY RELIEF DIPHENHYDRAMINE HCL 50 MG 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-020
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:73581-020-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2023
Labeler - YYBA Corporation (006339772)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835manufacture(73581-020) , analysis(73581-020) , pack(73581-020) , label(73581-020)

Revised: 8/2023
Document Id: 6f8bb858-3540-447e-a75b-86596b753ec3
Set id: 4b012549-3958-43c1-9de7-897c5d8b20d3
Version: 1
Effective Time: 20230801
 
YYBA Corporation