ALLERGY RELIEF DIPHENHYDRAMINE HCL 50 MG- diphenhydramine hcl capsule

Allergy Relief Diphenhydramine HCL 50 MG by

Drug Labeling and Warnings

Allergy Relief Diphenhydramine HCL 50 MG by is a Otc medication manufactured, distributed, or labeled by YYBA Corporation, Pharbest Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each banded capsule)

Diphenhydramine HCL 50 mg

Purpose

Antihistamine

Uses:

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat
• temporarily relieves these symptons due to common cold: 
• runny nose
• sneezing

Warnings:

Do not use

• to make a child sleepy
• With any other product containing Diphenhydramine HCL, even one used on skin

Ask a doctor before use if you have

• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

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:

• take every 4 to 6 hours, or as directed by a doctor
• do not exceed 6 doses in 24 hours

• adults and children 12 years and over: 1 capsule
• children under 12 years: ask a doctor

Other information

• Store at 20-25 °C (68-77 °F)

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)

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF DIPHENHYDRAMINE HCL 50 MG 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73581-020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	PH013
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73581-020-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/01/2023

Labeler - YYBA Corporation (006339772)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(73581-020) , analysis(73581-020) , pack(73581-020) , label(73581-020)