Drug Facts

Active ingredient (in each tablet)

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

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
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
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, or as directed by a doctor
do not take more than 6 times in 24 hours

adults and children 12 years and over	1 to 2 tablets
children 6 to under 12 years	1 tablet
children under 6 years	do not use

Other information

each tablet contains: calcium 45 mg
store between 20-25°C (68-77°F)
retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

PRINCIPAL DISPLAY PANEL

NDC 36800-909-01

TopCare® Health™

Compare to Benadryl® Allergy Tablets Active Ingredient*

Allergy Relief

Diphenhydramine HCl 25 mg

Antihistamine

Relief of:

Sneezing

Itchy, watery eyes

Runny Nose

Itchy Throat

Pharmacists Recommend

24 Tablets

image description

ALLERGY RELIEF
diphenhydramine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-909
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	25;052
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-909-01	2 in 1 CARTON	08/30/2011
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:36800-909-02	4 in 1 CARTON	08/30/2011
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:36800-909-03	1 in 1 CARTON	08/30/2011	04/30/2024
3		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:36800-909-05	400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/30/2011	07/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/30/2011

Labeler - TopCo Associates LLC (006935977)

TCR - 1090 - 2019-1016