Label: ALAVERT ALLERGY SINUS D-12- loratadine, pseudoephedrine sulfate tablet, film coated, extended release
- NDC Code(s): 0573-2660-12, 0573-2660-24
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated November 24, 2020
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- ACTIVE INGREDIENTS (IN EACH TABLET)
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- 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
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
- 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
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
Compare ours to the Active Ingredients in
Claritin-D® 12 Hour Tablets†
allergy & congestion
Pseudoephedrine Sulfate 120 mg/Nasal Decongestant
Loratadine 5 mg/Antihistamine — Extended Release Tablets
• 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.
*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 - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)