Label: CHILDRENS ALLERGY- loratadine solution
- NDC Code(s): 69842-535-08
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 2, 2017
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- Download DRUG LABEL INFO: PDF XML
- 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
CVS
Health™Compare to the active
ingredient in Children's Claritin®†Indoor & Outdoor
AllergiesNDC 69842-535-08
Children's
Allergy
24
HOURLORATADINE
ORAL SOLUTION USP5 mg/5 mL
Antihistamine
Allergy
Indoor & Outdoor Allergies
Non-Drowsy*
24 hour relief of:
Sneezing; Runny nose; Itchy,
watery eyes; Itchy throat or noseSugar free
2 Years & Older
*When taken as directed.
See Drug Facts Panel.DYE
FREEBubble Gum Flavor
Dosing Cup Enclosed
4 FL OZ (120 mL)
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INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-535 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) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PHOSPHORIC ACID (UNII: E4GA8884NN) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) Product Characteristics Color YELLOW (colorless to slightly yellow) Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-535-08 1 in 1 CARTON 12/12/2016 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 ANDA201865 12/12/2016 Labeler - CVS Pharmacy (062312574)