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healthy accents allergy relief

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: DZA Brands LLC
NDC Code: 55316-462

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.

DZA Brands, LLC Allergy Relief 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
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
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 (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 hour

adults and children 12 years and over

1 to 2 capsules

children 6 to under 12 years

1 capsule

children under 6 years

do not use

Other Safety Information
store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
each capsule is sealed with a Uni Band® seal which bonds the two capsule halves together. Do not use if seal is broken or missing. Do not use if blister unit is broken or torn.

Inactive ingredients

anhydrous lactose, benzyl alcohol, butylparaben, D&C red no. 28, edetate calcium disodium, edible ink, FD&C blue no. 1, FD&C red no. 40, gelatin, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate, sodium propionate

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

NO GLUTEN

24 capsules

HEALTHY ACCENTS ALLERGY RELIEF 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-462
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
BENZYL ALCOHOL 
BUTYLPARABEN 
D&C RED NO. 28 
EDETATE CALCIUM DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
SODIUM LAURYL SULFATE 
SODIUM PROPIONATE 
Product Characteristics
ColorPINK (clear) , WHITE (clear) , RED (band) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeL462
Contains    
Packaging
#Item CodePackage Description
1NDC:55316-462-6224 BLISTER PACK in 1 CARTON
11 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/29/2008
Labeler - DZA Brands LLC (090322194)

Revised: 01/2017
 
DZA Brands LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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