Label: LORATADINE tablet, chewable
- NDC Code(s): 11822-7240-0
- Packager: Rite Aid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 12, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton
RITE
AID®
PHARMACY*Compare to the active ingredient
in Children's Claritin® Chewableschildren's
allergy relief
loratadine chewable tablets USP, 5 mg
INDOOR &
OUTDOOR ALLERGIES
antihistamineNON-DROWSY†
24 hour relief of:
sneezing
runny nose
itchy, watery eyes
itchy throat or noseages 2 years
& older†WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.
grape flavored
ACTUAL
SIZE30
CHEWABLE
TABLETSThe chewable tablets are to be chewed before swallowing.
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-7240 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 5 mg Inactive Ingredients Ingredient Name Strength aspartame (UNII: Z0H242BBR1) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) D&C RED NO. 27 (UNII: 2LRS185U6K) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) magnesium stearate (UNII: 70097M6I30) mannitol (UNII: 3OWL53L36A) microcrystalline cellulose (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) stearic acid (UNII: 4ELV7Z65AP) Product Characteristics Color PURPLE (light to medium purple with a slightly speckled appearance) Score no score Shape ROUND (Flat face, beveled edge) Size 10mm Flavor GRAPE Imprint Code 753 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-7240-0 1 in 1 CARTON 04/01/2018 1 30 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 ANDA210088 04/01/2018 Labeler - Rite Aid (014578892) Registrant - Ohm Laboratories (184769029) Establishment Name Address ID/FEI Business Operations Ohm Laboratories 184769029 MANUFACTURE(11822-7240)