Label: LORATADINE tablet, chewable
- NDC Code(s): 51660-753-31
- Packager: Ohm Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 17, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctorbefore 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.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding, ask a health professional before.
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Directions
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- chew or crush tablets completely before swallowing.
adults and children 6 years and over
chew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of age
chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
- Other information
- Inactive ingredients
- Questions?
- Distributed by:
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Principal Display Panel – 30 Chewable Tablet Blister Pack Carton
NDC 51660-753-31
†Compare to the active ingredient of Children’s Claritin® Chewable
ages 2 years and older
Children’s
Loratadine Chewable Tablets USP, 5 mg
Antihistamine
Indoor & Outdoor Allergies
30 CHEWABLE TABLETS
The chewable tablets are to be chewed before swallowing.
Grape Flavored
Non-Drowsy*
24 Hour Relief Of:
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- Sneezing
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- Runny Nose
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- Itchy, Watery Eyes
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- Itchy Nose or Throat
*When taken as directed. See Drug Facts Panel.
†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-753 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) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color PURPLE (light purple to dark purple) Score no score Shape ROUND Size 10mm Flavor GRAPE Imprint Code 753 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51660-753-31 3 in 1 CARTON 06/01/2018 1 10 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 06/01/2018 Labeler - Ohm Laboratories Inc. (184769029) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 MANUFACTURE(51660-753)
