Allergy by Cardinal Health (Leader) 37205 DRUG FACTS

Allergy by

Drug Labeling and Warnings

Allergy by is a Otc medication manufactured, distributed, or labeled by Cardinal Health (Leader) 37205. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALLERGY ANTIHISTAMINE- diphenhydramine hcl capsule 
Cardinal Health (Leader) 37205

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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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

• 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 times 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

• read the directions, warnings and accompanying label information before use
• store at room temperature 15° to 30°C (59° to 86°F)

• protect from light

Inactive ingredients

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose, starch.

Questions or comments?

Call 1-800-200-6313 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Benadryl® Active Ingredient*

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl®

Allergy capsules

Diphenhydramine HCl 25 mg

Antihistamine

For allergy relief of:

• sneezing
• runny nose
• itchy throat
• itchy, watery eyes

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING

Product Label

Diphenhydramine HCl 25 mg capsules

ALLERGY  ANTIHISTAMINE
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-742
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
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK, WHITE	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	CPC835
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-742-62	2 in 1 CARTON	08/30/2012	06/30/2019
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 37205-742-78	1 in 1 BOX	08/30/2012	06/30/2019
2		100 in 1 BOTTLE; 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	08/30/2012	06/30/2019

Labeler - Cardinal Health (Leader) 37205 (097537435)

Revised: 6/2019

Document Id: e7ee991b-d988-4481-8b5f-8690498e9413

34390-5

Set id: 31929b64-88d8-400d-a8d9-d87aee774225

Version: 3

Effective Time: 20190625