DZA Brands, LLC Allergy Relief Drug Facts

healthy accents allergy relief by

Drug Labeling and Warnings

healthy accents allergy relief by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTHY ACCENTS ALLERGY RELIEF- diphenhydramine hydrochloride tablet 
DZA Brands 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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DZA Brands, LLC Allergy Relief 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
• itchy nose or throat
• temporarily relieves these symptoms of the common cold:
• runny nose
• sneezing

Warnings

Do not use

• with any other product containing diphenhydramine, even one used on skin
• to make a child sleepy

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
• excitability may occur, especially in children
• alcohol, sedatives and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

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:

  1 to 2 tablets

• children 6 to under 12 years:

  1 tablet

• children under 6 years:

  do not use

Other information

• each tablet contains: calcium 20 mg
• store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
• do not use if blister unit is broken or torn

Inactive ingredients

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-866-322-2439

Principal Display Panel

Compare to Benadryl® Allergy active ingredient

allergy relief

antihistamine - diphenhydramine HCl, 25mg

relieves:

sneezing

itchy, watery eyes - runny nose - itchy throat due to allergies & colds

actual size

24 tablets

gluten free

easy to swallow – mini-tabs

HEALTHY ACCENTS ALLERGY RELIEF 
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-479
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)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
D&C RED NO. 27 (UNII: 2LRS185U6K)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)

Product Characteristics
Color	PINK (dark)	Score	no score
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	L479
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-479-62	12 in 1 CARTON	01/29/2008	06/25/2019
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 55316-479-78	1 in 1 CARTON	01/29/2008	03/31/2020
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	part341	01/29/2008	03/31/2020

Labeler - DZA Brands LLC (090322194)

Revised: 12/2019

Document Id: 91220316-c268-4965-b75c-ede668fccc8e

34390-5

Set id: de87b059-ead2-495e-950c-275b87d59173

Version: 4

Effective Time: 20191211