Label: CHILDRENS LORATADINE ORAL- loratadine solution
- NDC Code(s): 0904-6767-20
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 25, 2020
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- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL teaspoonful)
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use if you have
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast feeding,
- Keep out of reach of children.
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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
- Inactive ingredients
-
Package/Label Principal Display Panel
Compare to the active ingredient in Children’s Claritin®
Children’s Loratadine Oral Solution, USP, 5 mg/5 mL
(Antihistamine)
ALLERGY
Non-Drowsy†
Indoor & Outdoor Allergies
SUGAR FREE
Dye Free
24 Hour Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
Ages 2 years and older
Dosing Cup Enclosed
Grape Flavor
†When taken as directed.
See Drug Facts Panel.
4 FL OZ (120 mL)
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INGREDIENTS AND APPEARANCE
CHILDRENS LORATADINE ORAL
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6767 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 EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) PHOSPHORIC ACID (UNII: E4GA8884NN) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-6767-20 1 in 1 CARTON 02/12/2019 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 ANDA075728 02/12/2019 Labeler - Major Pharmaceuticals (191427277)