COMPLETE ALLERGY ANTIHISTAMINE- diphenhydramine hcl tablet
Chain Drug Consortium, LLC

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

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 free: 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

**COMPARE TO ACTIVE INGREDIENT IN BENADRYL® ALLERGY ULTRATAB®

Complete Allergy Antihistamine

DIPHENHYDRAMINE HYDROCHLORIDE 25 MG

Relieves:

Sneezing
Itchy/Watery Eyes
Runny Nose or Itchy Throat due to Allergy & Colds

COATED MINITABS

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM, LLC.

3301 NW BOCA RATON BLVD., SUITE 101

BOCA RATON, FL 33431

Product Label

Premier value complete allergy antihistamine mini tabs

Diphenhydramine HCl 25 mg

COMPLETE ALLERGY ANTIHISTAMINE
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-227
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68016-227-24	2 in 1 CARTON	07/13/2010	01/31/2020
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:68016-227-57	1 in 1 BOX	07/13/2010	01/31/2020
2		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part336	07/13/2010	01/31/2020

Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 12/2018

Document Id: 448d4062-7ee0-45a9-bfca-b77f429eb756

Set id: 27227606-cf9c-442d-8786-1a0a61b7b2c5

Version: 6

Effective Time: 20181206

Chain Drug Consortium, LLC