FDA Label for Childrens Loratadine
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH 5 ML TEASPOONFUL)
- PURPOSE
- USES
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 120 ML BOTTLE CARTON
Childrens Loratadine Product Label
The following document was submitted to the FDA by the labeler of this product Taro Pharmaceuticals U.s.a., Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Active Ingredient (In Each 5 Ml Teaspoonful)
Loratadine 5 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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
- do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
- see bottom panel for lot number and expiration date
- store between 20° and 25°C (68° and 77°F)
Inactive Ingredients
glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium phosphate monobasic dihydrate, sucralose powder.
Questions?
Call 1-866-923-4914
Principal Display Panel - 120 Ml Bottle Carton
NDC 51672-2092-8
Compare to the
active ingredient
in Children's Claritin®*
Original
Prescription
Strength
Children's
Loratadine
Oral Solution
USP, 5 mg/5 mL
(Antihistamine)
ALLERGY
Non-Drowsy†
24 Hour
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Indoor & Outdoor Allergies
Ages 2 years and older
WARNING: Contains sodium metabisulfite,
a sulfite that may cause allergic-type reactions.
Dye Free
Sugar Free
Grape
Flavor
Dosage Cup
Enclosed
†When taken as directed.
See Drug Facts Panel.
4 FL OZ
(120 mL)
* Please review the disclaimer below.