Smart sense allergy relief d tablet, extended release

Active ingredient (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 Parkinsons 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

  • store between 20 to 25C (68 to 77F)

Inactive ingredients

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, yellow iron oxide

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Smart sense allergy relief d tablet, extended release- Cetirizine hcl, pseudoephedrine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 49738-709
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Cetirizine hydrochloride ( UNII: 64O047KTOA)( Cetirizine - UNII: YO7261ME24 ) 5 mgin 1
Pseudoephedrine hydrochloride ( UNII: 6V9V2RYJ8N)( Pseudoephedrine - UNII: 7CUC9DDI9F ) 120 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hydroxypropyl cellulose (1600000 wamw) ( UNII: RFW2ET671P)
Hypromelloses ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Talc ( UNII: 7SEV7J4R1U)
Ferric oxide yellow ( UNII: EX438O2MRT)

Product Characteristics

Color WHITE (one side white one side light yellow) Size 12 mm
Shape ROUND Score 1
Imprint Code 5029;5;120

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077170 USA

Labeler - Kmart Corporation( 008965873)

Principal display panel

ACTUAL SIZE

COMPARE TO ACTIVE INGREDIENTS IN ZYRTEC-D® EXTENDED RELEASE TABLETS

allergy & congestion

original prescription strength

allergy relief-D

CETIRIZINE HYDROCHLORIDE & PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE TABLETS, 5 mg / 120 mg

ANTIHISTAMINE / NASAL DECONGESTANT

INDOOR & OUTDOOR ALLERGIES

12 HOUR

12 HOUR RELIEF OF:

SNEEZING ITCHY, WATERY EYES

RUNNY NOSE ITCHY THROAT OR NOSE

SINUS PRESSURE NASAL CONGESTION

24 EXTENDED RELEASE TABLETS