Allergy by Cardinal Health (Leader) 37205 / P & L Development, LLC DRUG FACTS

Allergy by

Drug Labeling and Warnings

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

Drug Details [pdf]

ALLERGY ANTIHISTAMINE- diphenhydramine hydrochloride tablet 
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 tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves 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 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
• 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 this product in children under 6

Other information

• each tablet contains: calcium 25 mg/ tablet
• store at room temperature 15°-30°C (59°-86°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*, and titanium dioxide

* contains one or more of these ingredients

Principal Display Panel

Compare to  Benadryl® Allergy ultratab® 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 Ultratab®

Allergy Tablets

Diphenhydramine HCl 25 mg

Antihistamine

For allergy relief:

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

do not use if imprinted safety seal under cap is broken or missing

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Diphenhydramine HCl 25 mg tablets

ALLERGY  ANTIHISTAMINE
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-743
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)
DIBASIC CALCIUM PHOSPHATE 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	11mm
Flavor		Imprint Code	T61;V25;S4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-743-78	1 in 1 BOX	10/30/2012	12/31/2019
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 37205-743-62	1 in 1 BOX	10/30/2012	12/31/2019
2		24 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	10/30/2012	12/31/2019

Labeler - Cardinal Health (Leader) 37205 (097537435)

Registrant - P & L Development, LLC (800014821)

Revised: 12/2018

Document Id: c68bf779-a6a6-4dcb-b787-f19178e095d9

34390-5

Set id: 2ea7372b-a17b-4e31-8b0e-6a582b6860c0

Version: 3

Effective Time: 20181217

 

Cardinal Health (Leader) 37205