Label: DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable
- NDC Code(s): 11822-9999-3
- Packager: RITE AID
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 2, 2022
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- 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.
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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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton
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INGREDIENTS AND APPEARANCE
DYE-FREE CHILDRENS LORATADINE
loratadine tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-9999 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:11822-9999-3 3 in 1 CARTON 04/01/2022 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 04/01/2022 Labeler - RITE AID (014578892) Establishment Name Address ID/FEI Business Operations Ohm Laboratories 184769029 MANUFACTURE(11822-9999)