Cetirizine HCl and Pseudoephedrine HCl description, usages, side effects, indications, overdosage, supplying and lots more!

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Cetirizine HCl and Pseudoephedrine HCl

Physicians Total Care, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient (in each extended release tablet)

Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg

Purpose

Antihistamine

Nasal decongestant

Cetirizine HCl and Pseudoephedrine HCl Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • nasal congestion
    • sneezing
    • itching of the nose or throat
  • 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.


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

  • Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
  • DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN (for blister package only).

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, D & C yellow aluminum lake, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, and titanium dioxide.

Questions or comments?

1-800-525-8747

Sandoz Inc.

Princeton, NJ 08540

05-2010M



Relabeling of Additional Barcode by:
Physicians Total Care, Inc.
Tulsa, OK     74146

HOW SUPPLIED:


30 Tablets, Bottles              NDC 54868-5884-1

60 Tablets, Bottles              NDC 54868-5884-0

24 Tablets, Blister Pack      NDC 54868-5884-2

5 mg/120 mg Label

Cetirizine HCl and

Pseudoephedrine HCl

Extended Release Tablets

5 mg/120 mg

antihistamine/

nasal decongestant

Indoor & Outdoor Allergies

ALLERGY & CONGESTION

12 hour Relief of

Runny Nose Itchy, Watery Eyes Sinus Pressure

Sneezing Itchy Throat or Nose Nasal Congestion

Cetirizine HCl and Pseudoephedrine HCl

Cetirizine HCl and Pseudoephedrine HCl

Cetirizine HCl and Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54868-5884(NDC:0781-5285)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 5 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 120 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
ferric oxide red
FERRIC OXIDE YELLOW
HYPROMELLOSE 2208 (15000 CPS)
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol
polysorbate 80
povidone
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
yellow 10 mm SZ912 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BLISTER PACK
2 NDC:54868-5884-1 30 in 1 BOTTLE
3 NDC:54868-5884-0 60 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077991 2008-03-31


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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