Label: LORATADINE tablet, chewable
- NDC Code(s): 49035-953-30
- Packager: Wal-Mart Stores, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 11, 2024
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 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.
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton
NDC 49035-953-30
equate™
Compare to
Children's Claritin®
Chewables active
ingredient*children ★s Non-Drowsy**
LORATADINE CHEWABLE
Tablets USP, 5mg
Antihistamine24
HOURSAGES 2 YEARS AND OLDER
Indoor & Outdoor Allergies
Grape Flavored
30 Chewable Tablets
The chewable tablets are to be chewed before swallowing.
Relief of:
- Sneezing
- Runny nose
- Itchy, watery eyes
- Itchy throat or nose
**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:49035-953 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) D&C RED NO. 27 (UNII: 2LRS185U6K) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) 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 purple (light purple to dark purple) Score no score Shape ROUND Size 10mm Flavor GRAPE Imprint Code 753 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-953-30 3 in 1 CARTON 05/01/2018 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 ANDA210088 05/01/2018 Labeler - Wal-Mart Stores, Inc (051957769) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 manufacture(49035-953)