Label: DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable
- NDC Code(s): 79903-008-30
- 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
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- 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.
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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 79903-008-30
equate™
Compare to
Children's Claritin®
Chewables active
ingredient*childrens Non-Drowsy**
LORATADINE CHEWABLE
Tablets USP, 5mg
Antihistamine24
HOURSDye-Free
AGES 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
DYE-FREE CHILDRENS LORATADINE
loratadine tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79903-008 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 Size 10mm Flavor GRAPE Imprint Code 106 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79903-008-30 3 in 1 CARTON 01/01/2021 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 01/01/2021 Labeler - WAL-MART STORES, INC (051957769) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 manufacture(79903-008)