Label: TOPCARE ALLERGY RELIEF- loratadine tablet, orally disintegrating
- NDC Code(s): 36800-853-65
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 29, 2021
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
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
COMPARE TO CLARITIN® REDITABS® ACTIVE INGREDIENT†
NON-DROWSY*
ORIGINAL PRESCRIPTION STRENGTH
Allergy Relief
LORATADINE ORALLY DISINTEGRATING TABLETS, 10 mg – ANTIHISTAMINE
INDOOR & OUTDOOR ALLERGIES
24 HOUR
RELIEF OF:
● Sneezing
● Runny Nose
● Itchy, Watery Eyes
● Itchy Throat or Nose
No Water Needed
Melts in Your Mouth
30 TABLETS
*When taken as directed. See Drug Facts Panel.
actual size
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INGREDIENTS AND APPEARANCE
TOPCARE ALLERGY RELIEF
loratadine tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-853 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code L;L Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-853-65 30 in 1 CARTON 06/25/2020 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 ANDA076011 06/25/2020 Labeler - Topco Associates LLC (006935977)