Label: DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable
- NDC Code(s): 11673-111-30
- Packager: UP & UP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 19, 2020
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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 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.
-
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
Compare to active ingredient in Children's
Claritin® Chewables*NDC 11673-111-30
dye-free
children's
allergyloratadine chewable tablets USP, 5 mg
antihistaminenon-drowsy**
indoor and outdoor allergies
24-hour relief of:- sneezing
- runny nose
- itchy, watery eyes
- itchy throat or nose
**When taken as directed. See drug facts panel.
up & up
GRAPE
FLAVORACTUAL SIZE
30
CHEWABLE
TABLETS30 CHEWABLE TABLETS
THE CHEWABLE TABLETS ARE
TO BE CHEWED BEFORE SWALLOWING -
INGREDIENTS AND APPEARANCE
DYE-FREE CHILDRENS LORATADINE
loratadine tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-111 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:11673-111-30 3 in 1 CARTON 11/17/2020 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 11/17/2020 Labeler - UP & UP (006961700) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 MANUFACTURE(11673-111)