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Alavert D-12 Hour Allergy and Sinus Prescribing Information

Package insert / product label
Generic name: loratadine, pseudoephedrine sulfate
Dosage form: tablet, film coated, extended release
Drug class: Upper respiratory combinations

Medically reviewed by Drugs.com. Last updated on Feb 28, 2024.

ACTIVE INGREDIENTS (IN EACH TABLET)

Loratadine 5 mg

Pseudoephedrine sulfate 120 mg

PURPOSES

Antihistamine

Nasal decongestant

Indications and Usage for Alavert D-12 Hour Allergy and Sinus

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).

Alavert D-12 Hour Allergy and Sinus Dosage and Administration

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

Storage and Handling

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)

Distributed by: Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL

NDC 0573-2660-24

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.

PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton
ALAVERT ALLERGY SINUS D-12
loratadine, pseudoephedrine sulfate tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2660
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE120 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (white to off-white) Scoreno score
ShapeROUND (round shape and an extra deep convex) Size14mm
FlavorImprint CodeAlavert;D12
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-2660-122 in 1 CARTON01/30/2004
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0573-2660-244 in 1 CARTON01/30/2004
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07605001/30/2004
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)