ALLERGY- diphenhydramine hcl capsule
TOP CARE (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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Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

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

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
be careful 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.

Directions

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

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

Other information

store between 15-30ºC (59-86ºF)
protect from light

Inactive ingredients

butylparaben*, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, FD&C yellow #6*, gelatin, lactose*, lactose monohydrate*, magnesium stearate*, methylparaben*, polysorbate 80*, propylparaben*, purified water*, sodium lauryl sulphate*, starch

*contains one or more of these ingredients

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

MULTI-SYMPTOM

ALLERGY Capsules

Diphenhydramine HCl 25 mg Antihistamine

For Allergy Relief

•Sneezing •Runny Nose •Itchy, Watery Eyes •Itchy Throat

Capsules

Each capsule individually banded for your protection

COMPARE TO BENADRYL® active ingredient**

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl®.

DISTRIBUTED BY TOPCO ASSOICATES LLC

ELK GROVE VILLAGE, IL 60007

QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrand.com

TAMPER EVIDENT: CAPSULE BANDED FOR YOUR PROTECTION. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

TopCare Multi-Symptom Allergy Capsules

ALLERGY
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-781
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)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK, WHITE	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	P25;CPC835
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-781-62	24 in 1 CARTON	07/15/2016	12/30/2020
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:36800-781-78	1 in 1 BOX	07/15/2016	12/30/2020
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	07/15/2016	12/30/2020

Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 10/2019

Document Id: d238b637-e8c8-4654-a8d5-1faa8dbf1a08

Set id: 72a1d17e-f3b2-49a0-8527-dc87e14008c9

Version: 4

Effective Time: 20191014

TOP CARE (Topco Associates LLC)