Label: LORATADINE tablet, chewable
- NDC Code(s): 0363-9994-30
- Packager: WALGREENS CO.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 9, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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
-
PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton
NDC 0363-9994-30
Walgreens
Compare to the active ingredient
in Children's Claritin ®Chewables ††• WALGREENS •
PHARMACIST RECOMMENDED†Children's
Allergy ReliefLORATADINE CHEWABLE TABLETS USP, 5 mg / ANTIHISTAMINE
Dye Free
Non-Drowsy*
24-Hour Relief- 24-hour relief of sneezing, runny nose, itchy throat or nose, & itchy, watery eyes
- Indoor & outdoor allergies
AGES
2
YEARS &
OLDER30 CHEWABLE TABLETS
Chewable tablets are to be chewed before swallowing.ACTUAL SIZE
Grape
flavor*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.
-
INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9994 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) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (beveled edge) Size 10mm Flavor GRAPE Imprint Code 106 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9994-30 3 in 1 CARTON 08/01/2020 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 08/01/2020 Labeler - WALGREENS CO. (008965063) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 MANUFACTURE(0363-9994)