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
Updated July 17, 2019
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- Active ingredient (in each tablet)
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.
- 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
- Distributed by:
Principal Display Panel – 30 Chewable Tablet Blister Pack Carton
†Compare to the active ingredient of Children’s Claritin® Chewable
ages 2 years and older
Loratadine Chewable Tablets USP, 5 mg
Indoor & Outdoor Allergies
30 CHEWABLE TABLETS
The chewable tablets are to be chewed before swallowing.
24 Hour Relief Of:
- Runny Nose
- Itchy, Watery Eyes
- 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.
INGREDIENTS AND APPEARANCE
loratadine tablet, chewable
Product 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)