Label: DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable
- NDC Code(s): 11822-8329-7
- Packager: RITE AID
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 12, 2021
If you are a consumer or patient please visit this version.
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- 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
- 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
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PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton
FREE
FROM
DYE FREE24 HOUR
NDC 11822-8329-7
Compare to the active
ingredient of Children's
Claritin® Chewables**AGES 2 YEARS & OLDER
CHILDREN'S
ALLERGY RELIEFCHEWABLE TABLETS • ANTIHISTAMINE
DYE-FREELORATADINE CHEWABLE TABLETS USP, 5 mg
NON-DROWSY* INDOOR / OUTDOOR ALLERGIES
24 HOUR RELIEF OF
Sneezing • Runny nose • Itchy, watery eyes
Itchy throat or noseACTUAL SIZE
GRAPE
FLAVOR
30
CHEWABLE TABLETS*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.
THE CHEWABLE TABLETS ARE TO BE CHEWED BEFORE SWALLOWING.
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INGREDIENTS AND APPEARANCE
DYE-FREE CHILDRENS LORATADINE
loratadine tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-8329 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 (bevelled edge) Size 10mm Flavor GRAPE Imprint Code 106 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-8329-7 3 in 1 CARTON 09/01/2020 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 09/01/2020 Labeler - RITE AID (014578892) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 MANUFACTURE(11822-8329)