HEALTH MART ALLERGY COMPLETE D- cetirizine hydrochloride, pseudoephedrine hydrochloride tablet, film coated, extended release 
Strategic Sourcing Services LLC

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McKesson Allergy Complete-D Drug Facts

Active ingredients (in each extended release tablet)

Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg

Purpose

Antihistamine

Nasal decongestant

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
nasal congestion
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

heart disease
thyroid disease
diabetes
glaucoma
high blood pressure
trouble urinating due to an enlarged prostate gland
liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product

do not use more than directed
drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.
you get nervous, dizzy, or sleepless
symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding:

if breast-feeding: not recommended
if pregnant: 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

do not break or chew tablet; swallow tablet whole
 
adults and children 12 years and over
 
take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
 
adults 65 years and over
 
ask a doctor
 
children under 12 years of age
 
ask a doctor
 
consumers with liver or kidney disease
 
ask a doctor

Other information

store between 20° to 25°C (68° to 77°F)
do not use if blister unit is broken or torn
see side panel for lot number and expiration date
meets USP Dissolution Test 2

Inactive ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Zyrtec-D® active ingredients

ORIGINAL PRESCRIPTION STRENGTH

12 Hour

Allergy Complete-D

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets, 5 mg/120 mg

Antihistamine/Nasal Decongestant

ALLERGY & CONGESTION

Actual Size

Indoor & Outdoor Allergies

12 Hour Relief of: Sneezing; Itchy, Watery Eyes; Runny Nose; Itchy Throat or Nose; Sinus Pressure; Nasal Congestion

24 Extended Release Tablets

Gluten Free

Allergy Complete-D Carton Image 1
Allergy Complete-D Carton Image 2
HEALTH MART ALLERGY COMPLETE D 
cetirizine hydrochloride, pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0411
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code L147
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62011-0411-124 in 1 CARTON03/04/2020
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21071903/04/2020
Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 9/2020
Document Id: e0431b2e-53c1-461f-9400-b53dbcb77329
Set id: a09f404e-9be5-4a34-9ca9-f166721b9644
Version: 2
Effective Time: 20200903
 
Strategic Sourcing Services LLC