Label: LORATADINE D- loratadine, pseudoephedrine sulfate tablet, film coated, extended release
- NDC Code(s): 45802-122-46, 45802-122-60, 45802-122-65
- Packager: Padagis Israel Pharmaceuticals Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 11, 2021
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- Official Label (Printer Friendly)
- Active ingredients (in each tablet)
- Purpose
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Uses
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- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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- sneezing
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- itchy, watery eyes
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- runny nose
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- itching of the nose or throat
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- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
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- reduces swelling of nasal passages
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- temporarily relieves sinus congestion and pressure
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- temporarily restores freer breathing through the nose
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Warnings
Do not use
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- if you have ever had an allergic reaction to this product or any of its ingredients
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- 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
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- heart disease
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- thyroid disease
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- high blood pressure
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- 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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Package/Label Principal Display Panel
Compare to Claritin-D® 12 Hour active ingredients
Loratadine-D
12 Hour
Pseudoephedrine Sulfate 120 mg / Loratadine 5 mg
Extended Release Tablets
Nasal Decongestant / Antihistamine
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
actual size
20 Tablets
Non-Drowsy*
*When taken as directed.
See Drug Facts Panel.
12 Hour Allergy & Congestion
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INGREDIENTS AND APPEARANCE
LORATADINE D
loratadine, pseudoephedrine sulfate tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45802-122 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 (to off-white) Score no score Shape ROUND Size 12mm Flavor Imprint Code 7U0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45802-122-46 10 in 1 CARTON 04/10/2018 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:45802-122-60 20 in 1 CARTON 04/10/2018 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:45802-122-65 30 in 1 CARTON 04/10/2018 3 1 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 04/10/2018 Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)