Label: CHILDRENS LORATADINE SUGAR FREE- loratadine solution
- NDC Code(s): 70677-1058-1
- Packager: STRATEGIC SOURCING SERVICES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 19, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL teaspoonful)
- Purpose
- Uses
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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
- use only with enclosed dosing cup
adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) 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
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PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
NDC 70677-1058-1
COMPARE TO CHILDREN'S
CLARITIN® ACTIVE INGREDIENT*Foster & Thrive™
ORIGINAL PRESCRIPTION STRENGTH
Children's
AllergyLoratadine Oral Solution
USP, 5 mg/5 mL
ANTIHISTAMINE AllergyIndoor & Outdoor Allergies
24 hour relief of:- Runny Nose
- Itchy, Watery Eyes
- Sneezing
- Itchy Throat or Nose
Sugar Free | Non-Drowsy**
Ages 2 years & older
Dye Free
GRAPE FLAVOR
DOSING CUP ENCLOSED** WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.
4 FL OZ (120 mL)
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INGREDIENTS AND APPEARANCE
CHILDRENS LORATADINE SUGAR FREE
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1058 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) MALTITOL (UNII: D65DG142WK) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PHOSPHORIC ACID (UNII: E4GA8884NN) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) Product Characteristics Color YELLOW (colorless to slightly yellow) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1058-1 1 in 1 CARTON 07/19/2023 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076805 07/19/2023 Labeler - STRATEGIC SOURCING SERVICES LLC (116956644) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(70677-1058)