ALLERGY- diphenhydramine hcl capsule

Allergy by

Drug Labeling and Warnings

Allergy 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 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

INGREDIENTS AND APPEARANCE

ALLERGY 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-781
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
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/15/2016	12/30/2020

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