Leader allergy d 12 tablet, extended release

Active ingredient (in each extended release tablet)

Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg

Purpose

Antihistamine

Nasal Decongestant

Uses

  1. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  2. runny nose
  3. sneezing
  4. itchy, watery eyes
  5. itching of the nose or throat
  6. nasal congestion
  7. reduces swelling of nasal passages
  8. temporarily relieves sinus congestion and pressure
  9. temporarily restores freer breathing through the nose

Warnings

Do not use

  1. if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
  2. 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

  1. heart disease
  2. thyroid disease
  3. diabetes
  4. glaucoma
  5. high blood pressure
  6. trouble urinating due to an enlarged prostate gland
  7. 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

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

Stop use and ask a doctor if

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

If pregnant or breast-feeding:

  1. if breast-feeding: not recommended
  2. 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

  1. 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

  1. 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

Leader allergy d 12 tablet, extended release- Cetirizine hcl, pseudoephedrine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 37205-827
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 - Cardinal Health( 097537435)

Principal display panel

Compare to Zyrtec-D® active ingredients

Indoor & Outdoor Allergies

Original Prescription Strength

Allergy D-12

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

Antihistamine/Nasal Decongestant

Allergy & Congestion

12 Hour Relief of:

Sneezing

Itchy Throat or Nose

Itchy, Watery Eyes

Runny Nose

Sinus Pressure

Nasal Congestion

Actual Size

Allergy D-12 Carton

Allergy D-12 Carton