TOPCARE ALLERGY- diphenhydramine hydrochloride 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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Topco Associates LLC. Allergy Capsules 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:
•: runny nose
•: sneezing
•: itchy, watery eyes
•: itching of the nose or throat
•: temporarily relieves these symptoms due to the common cold:
•: runny nose
•: sneezing

Warnings

Do not use

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

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

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. (1-800-222-1222)

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 this product in children under 6 years of age

Inactive ingredients

anhydrous lactose, benzyl alcohol, butylparaben, D&C red no. 28, edetate calcium disodium, edible ink, FD&C blue no. 1, FD&C red no. 40, gelatin, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate, sodium propionate

Questions or comments?

1-888-423-0139

Principal Display Panel

EASY-TO-SWALLOW

Allergy Capsules

DIPHENHYDRAMINE HCl 25 mg EACH / ANTIHISTAMINE

For allergy relief

Sneezing

Itchy, watery eyes

Runny nose

Itchy throat

actual size

COMPARE TO BENADRYL® ALLERGY active ingredient

Allergy Capsules Carton Image 1

Allergy Capsules Carton Image 2

TOPCARE ALLERGY
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-462
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PROPIONATE (UNII: DK6Y9P42IN)

Product Characteristics
Color	PINK (clear) , WHITE (clear) , RED (band)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	L462
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-462-62	2 in 1 CARTON	01/15/1988	09/09/2014
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:36800-462-67	4 in 1 CARTON	01/15/1988	09/09/2014
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:36800-462-78	1 in 1 CARTON	01/15/1988	09/09/2014
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:36800-462-68	3 in 1 CARTON	01/15/1988	09/09/2014
4		12 in 1 BLISTER PACK; 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	01/15/1988	09/09/2014

Labeler - Topco Associates LLC (006935977)

Revised: 11/2017

Document Id: d4c9ec61-60f6-4e82-a4e9-c4c08fb35050

Set id: b199a8c5-7345-4772-81c8-a965be0f5bd3

Version: 3

Effective Time: 20171110

Topco Associates LLC