CIRCLE K ALLERGY ANTIHISTAMINE- diphenhydramine hydrochloride tablet, film coated

Circle K Allergy by

Drug Labeling and Warnings

Circle K Allergy by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc., Elysium Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• 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 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 doses in 24 hours

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

Other information

• each tablet contains: calcium 25 mg
• store at 68°-77°F (20°-25°C)
• 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, lecithin1, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, polyvinyl alcohol1, purified water1, talc1, titanium dioxide

1 contains one or more of these ingredients

Questions or comments ?

Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

SPL UNCLASSIFIED SECTION

Proudly distributed by Circle K Stores Inc.

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton - NDC:

66715-5354-0

Compare to the Active Ingredient
in Benadryl® Allergy**

CIRCLE K™

Allergy

Diphenhydramine HCl 25 mg, Antihistamine

ACTUAL SIZE

Relieves

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

24 Tablets

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton - NDC:

66715-5454-0

Compare to the Active Ingredient
in Benadryl® Allergy**

CIRCLE K™

Allergy

Diphenhydramine HCl 25 mg, Antihistamine

ACTUAL SIZE

Relieves

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

24 Tablets

INGREDIENTS AND APPEARANCE

CIRCLE K ALLERGY   ANTIHISTAMINE
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-5354
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 Aluminum Lake (UNII: ZK64F7XSTX)
Dibasic Calcium Phosphate Dihydrate (UNII: O7TSZ97GEP)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Egg Phospholipids (UNII: 1Z74184RGV)
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Polyvinyl Alcohol, Unspecified (UNII: 532B59J990)
Water (UNII: 059QF0KO0R)
Talc (UNII: 7SEV7J4R1U)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	V;25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-5354-0	2 in 1 CARTON	01/30/2017
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	11/01/2014

CIRCLE K ALLERGY   ANTIHISTAMINE
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-5454
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 Aluminum Lake (UNII: ZK64F7XSTX)
Dibasic Calcium Phosphate Dihydrate (UNII: O7TSZ97GEP)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Egg Phospholipids (UNII: 1Z74184RGV)
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Polyvinyl Alcohol, Unspecified (UNII: 532B59J990)
Water (UNII: 059QF0KO0R)
Talc (UNII: 7SEV7J4R1U)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	S4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-5454-0	2 in 1 CARTON	01/30/2017
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	11/01/2014

Labeler - Lil' Drug Store Products, Inc. (093103646)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Limited		915664486	MANUFACTURE(66715-5454) , ANALYSIS(66715-5454) , PACK(66715-5454) , LABEL(66715-5454)