Label: CHILDRENS LORATADINE ODT- loratadine tablet, orally disintegrating
- NDC Code(s): 0363-4020-84
- Packager: WALGREEN CO.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 4, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use if you have
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 30 (3 x 10) Orally Disintegrating Tablets
Walgreens
free+pure†
Junior's
Allergy Relief
Loratadine orally disintegrating tablets USP 10 mg, antihistamine
Compare to the active ingredient
in Claritin® RediTabs®††
Dissolvable tablet
Melts in mouth with no water needed
Non-drowsy‡ Indoor & outdoor allergies24-hour relief of sneezing, runny nose,
itchy, watery eyes & itchy throat or nose†Free+Pure is:
• No artificial flavors • Gluten free*
• No synthetic colors • Non-GMO
AGES 6 YEARS & OLDER
Actual size 30
orally disintegrating tablets
‡WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.
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INGREDIENTS AND APPEARANCE
CHILDRENS LORATADINE ODT
loratadine tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4020 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PEPPERMINT (UNII: V95R5KMY2B) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) Product Characteristics Color WHITE (White to Off-white) Score no score Shape ROUND (Biconvex) Size 8mm Flavor PEPPERMINT Imprint Code K;9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-4020-84 3 in 1 CARTON 04/11/2018 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 ANDA208477 04/11/2018 Labeler - WALGREEN CO. (008965063) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(0363-4020) , MANUFACTURE(0363-4020)