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Home > Drugs > Upper respiratory combinations > Alavert d-12 > Alavert D-12 Hour Allergy and Sinus Prescribing Information
Upper respiratory combinations
https://themeditary.com/pro/alavert-d-12-hour-allergy-and-sinus-prescribing-information-14740.html

Alavert D-12 Hour Allergy and Sinus Prescribing Information

Drug Detail:Alavert d-12 (Loratadine and pseudoephedrine [ lor-at-a-deen-and-soo-doe-ee-fed-rin ])

Drug Class: Upper respiratory combinations

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

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)

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