Label: DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable
- NDC Code(s): 51660-112-31
- Packager: Ohm Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 15, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each chewable tablet)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.
When using this productdo not take more than directed. Taking more than directed may cause drowsiness.
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Directions
- chew or crush tablets completely before swallowing.
adults and children 6 years and over
chew 2 tablets daily; not more than 2 chewable tablets in 24 hours
children 2 to under 6 years of age
chew 1 tablet daily; not more than 1 chewable 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?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 5 mg Tablet
NDC 51660-112-31
†Compare to the active ingredient of Children's Claritin ®Chewable
Ages 2+ years
Children's
Loratadine Chewable Tablets USP, 5 mg
Antihistamine
Indoor & Outdoor Allergies
30 CHEWABLE TABLETS
The chewable tablets are to be chewed before swallowing.
Dye-Free
Bubble Gum Flavored
Non-Drowsy*
24 Hour Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
*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
DYE-FREE CHILDRENS LORATADINE
loratadine tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-112 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) 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 white (white to off-white) Score no score Shape ROUND (beveled edge) Size 10mm Flavor BUBBLE GUM Imprint Code 112 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51660-112-31 3 in 1 CARTON 08/19/2020 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 08/19/2020 Labeler - Ohm Laboratories Inc. (184769029) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 manufacture(51660-112)