ALLERGY RELIEF- diphenhydramine hydrochloride tablet

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• 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 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 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 doses in 24 hours

• adults and children 12 years of age and over: take 1 to 2 tablets
• children 6 to under 12 years of age: take 1 tablet
• children under 6 years of age: do not use

Other information

• each tablet contains: calcium 25 mg
• store between 20-25°C (68-77°F)
• protect from light and moisture

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, titanium dioxide

* contains one or more of these ingredients

Questions or comments?

Call toll free1-888-423-0139

Principal Display Panel

COMPLETE ALLERGY RELIEF

Allergy Relief Tablets

DIPHENHYDRAMINE HCl, 25 mg  ANTIHISTAMINE

For allergy relief

Sneezing  Runny Nose Itchy,Watery Eyes Itchy Nose & Throat

COMPARE TO BENADRYL® ALLERGY active ingredient**

TABLETS

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL  60007

1-888-423-0139 ©TOPCO  topcare@topco.com

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

TopCare Allergy Relief Tablets

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-690
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALUMINUM OXIDE (UNII: LMI26O6933)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	12mm
Flavor		Imprint Code	T61;V25;S4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-690-36	3 in 1 CARTON	03/31/2013	12/30/2020
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 36800-690-62	24 in 1 CARTON	03/31/2013	12/30/2020
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 36800-690-67	48 in 1 CARTON	03/31/2013	12/30/2020
3		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 36800-690-78	1 in 1 BOX	03/31/2013	12/30/2020
4		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part336	03/31/2013	12/30/2020

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