ALLERGY RELIEF- diphenhydramine hcl capsule
Topco Associates, LLC

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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TopCare 44-190-Discontinued

Active ingredient (in each banded capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the 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 beverages
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 of 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 (1-800-222-1222) right away.

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

adults and children 12 years and over	1 to 2 capsules
children 6 to under 12 years	1 capsule
children under 6 years	do not use

Other information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from moisture
use by expiration date on package

Inactive ingredients

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide

Questions or comments?

Call 1-888-423-0139

Principal Display Panel

+TopCare®
health™

NDC 36800-891-51

COMPARE TO BENADRYL® ACTIVE INGREDIENT*

Allergy
Relief
DIPHENHYDRAMINE HCl, 25 mg • ANTIHISTAMINE

Allergy Relief from:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat

365 CAPSULES

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0118 QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com

QUALITY GUARANTEED

50844 ORG111719051

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.

Topcare 44-190

ALLERGY RELIEF
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-891
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLPARABEN (UNII: 3QPI1U3FV8)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	PINK, WHITE	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	44;107
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-891-51	365 in 1 BOTTLE; Type 0: Not a Combination Product	03/15/1990	03/06/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	03/15/1990	03/06/2021

Labeler - Topco Associates, LLC (006935977)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	MANUFACTURE(36800-891) , PACK(36800-891)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(36800-891)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(36800-891)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(36800-891)

Revised: 3/2019

Document Id: 1777d4f3-ee5d-417b-b1f7-a15a906feb44

Set id: 2bd0b272-78de-4e1f-947f-d1d7a67f3c6b

Version: 4

Effective Time: 20190328

Topco Associates, LLC