Label: LEADER ALLERGY RELIEF D-24- loratadine and pseudoephedrine sulfate tablet, film coated, extended release
- NDC Code(s): 70000-0162-1, 70000-0162-2
- Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 22, 2022
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
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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
■ reduces swelling of nasal passages
■ temporarily relieves sinus congestion and pressure
■ temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
■ temporarily restores freer breathing through the nose
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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.
- Directions
- Other Information
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InactiveIngredients
calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide
- Questions
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Package/Label Principal Display Panel
NDC 70000-0162-1
Original Prescription Strength
*Compare to the active ingredients of Claritin-D® 24 Hour
NON-DROWSY*
Allergy Relief D-24
Loratadine, USP 10 mg/Antihistamine
Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant
Indoor & Outdoor Allergies
Allergy & Congestion
Relief of:
Nasal & Sinus Congestion Due to Colds or Allergies
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose Due to Allergies
Allergy & Congestion
10 Extended-Release Tablets
*When taken as directed. See Drug Facts Panel.
Keep the carton. It contains important information.
see end panel for expiration date.
-
Principal Display Panel
NDC 70000-0162-2
Original Prescription Strength
*Compare to the active ingredients of Claritin-D® 24 Hour
NON-DROWSY**
Allergy Relief D-24
Loratadine, USP 10 mg/Antihistamine
Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant
Indoor & Outdoor Allergies
Allergy & Congestion
Relief of:
Nasal & Sinus Congestion Due to Colds or Allergies
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose Due to Allergies
Allergy & Congestion
15 Extended-Release Tablets
*When taken as directed. See Drug Facts Panel.
Keep the carton. It contains important information.
see end panel for expiration date.
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INGREDIENTS AND APPEARANCE
LEADER ALLERGY RELIEF D-24
loratadine and pseudoephedrine sulfate tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0162 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE 240 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) SHELLAC (UNII: 46N107B71O) SODIUM ALGINATE (UNII: C269C4G2ZQ) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color white Score no score Shape CAPSULE Size 17mm Flavor Imprint Code RX724 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0162-1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 01/15/2020 2 NDC:70000-0162-2 15 in 1 BLISTER PACK; Type 0: Not a Combination Product 01/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076557 02/15/2017 Labeler - Cardinal Health (063997360) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 MANUFACTURE(70000-0162)
