Label: TOPCARE ALLERGY AND CONGESTION RELIEF- loratadine, pseudoephedrine sulfate tablet, extended release
- NDC Code(s): 36800-706-22
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 29, 2023
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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
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?
-
Package/Label Principal Display Panel
TopCare® health
COMPARE TO CLARITIN-D® 24 HOUR EXTENDED RELEASE TABLETS
ACTIVE INGREDIENTS
NON-DROWSY*
Allergy & Congestion Relief
PSEUDOEPHEDRINE SULFATE 240 mg • LORATADINE 10 mg EXTENDED RELEASE TABLETS
NASAL DECONGESTANT • ANTIHISTAMINE
INDOOR & OUTDOOR ALLERGIES
24 HOUR
RELIEF OF:
• Nasal and Sinus Congestion Due to Colds or Allergies
• Sneezing • Runny Nose • Itchy, Watery Eyes
• Itchy Throat or Nose Due to Allergies
15 EXTENDED RELEASE TABLETS
*When taken as directed. See Drug Facts Panel.
actual size
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INGREDIENTS AND APPEARANCE
TOPCARE ALLERGY AND CONGESTION RELIEF
loratadine, pseudoephedrine sulfate tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-706 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape OVAL Size 19mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-706-22 15 in 1 CARTON 08/16/2023 1 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 ANDA075989 08/16/2023 Labeler - Topco Associates LLC (006935977)