ALAVERT ALLERGY SINUS D-12- loratadine, pseudoephedrine sulfate tablet, film coated, extended release

ALAVERT ALLERGY SINUS D-12 by

Drug Labeling and Warnings

ALAVERT ALLERGY SINUS D-12 by is a Otc medication manufactured, distributed, or labeled by Wyeth Consumer Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH TABLET)

Loratadine 5 mg

Pseudoephedrine sulfate 120 mg

PURPOSES

Antihistamine

Nasal decongestant

USES

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itchy, watery eyes
  • runny nose
  • itching of the nose or throat
• temporarily relieves nasal congestion due to the common cold, hay fever or other respiratory allergies
• 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
• 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
• high blood pressure
• diabetes
• trouble urinating due to an enlarged prostate gland
• liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed.

Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

• an allergic reaction to this product occurs. Seek medical help right away.
• symptoms do not improve within 7 days or are accompanied by a fever
• nervousness, dizziness or sleeplessness occurs

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

• do not divide, crush, chew or dissolve the tablet

• adults and children 12 years and over: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
• children under 12 years of age: ask a doctor
• consumers with liver or kidney disease: ask a doctor

OTHER INFORMATION

• each tablet contains: calcium 25 mg
• store between 20° and 25°C (68° and 77°F)
• keep in a dry place

INACTIVE INGREDIENTS

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM to 5 PM EST at 1-800-ALAVERT (1-800-252-8378)

SPL UNCLASSIFIED SECTION

Distributed by: Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton

Compare ours to the Active Ingredients in
Claritin-D® 12 Hour Tablets†

allergy & congestion

ALAVERT®
D-12
HOUR

Pseudoephedrine Sulfate 120 mg/Nasal Decongestant
Loratadine 5 mg/Antihistamine — Extended Release Tablets

Non-Drowsy*
Relief of:
Nasal and Sinus Congestion Due to Colds or Allergies
Sneezing Runny Nose Itchy, Watery Eyes
Itchy Throat or Nose Due to Allergies

Indoor & Outdoor Allergies

†This product is not manufactured by Bayer HealthCare LLC, the distributor of Claritin-D® 12 Hour Tablets.

24 TABLETS

Actual Size

*When taken as directed.
See Drug Facts Panel.

INGREDIENTS AND APPEARANCE

ALAVERT ALLERGY SINUS D-12 
loratadine, pseudoephedrine sulfate tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-2660
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE SULFATE	120 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (white to off-white)	Score	no score
Shape	ROUND (round shape and an extra deep convex)	Size	14mm
Flavor		Imprint Code	Alavert;D12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-2660-12	2 in 1 CARTON	01/30/2004
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0573-2660-24	4 in 1 CARTON	01/30/2004
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076050	01/30/2004

Labeler - Wyeth Consumer Healthcare LLC (828831730)