FDA Label for Dye-free Childrens Loratadine
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- 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 - 5 MG TABLET BLISTER PACK CARTON
Dye-free Childrens Loratadine Product Label
The following document was submitted to the FDA by the labeler of this product Ohm Laboratories 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:
Ohm Laboratories Inc.
New Brunswick, NJ 08901
0420
Active Ingredient (In Each Tablet)
Loratadine USP, 5 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose• sneezing• itchy, watery eyes• 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
• 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
• phenylketonurics: contains phenylalanine 1.25 mg per tablet.• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.• store between 20° to 25°C (68° to 77°F).
Inactive Ingredients
aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
Questions?
call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.
Keep the carton. It contains important information. See end panel for expiration date.
Principal Display Panel - 5 Mg Tablet Blister Pack Carton
NDC 51660-106-31
†Compare to the active ingredient of Children's Claritin® Chewable
ages 2 years and older
Children's
Loratadine Chewable Tablets USP, 5 mg
Antihistamine
Indoor & Outdoor Allergies
30 CHEWABLE TABLETS
The chewable tablets are to be chewed before swallowing.
Dye-Free
Grape Flavored
Non-Drowsy*
24 Hour Relief of:
• Sneezing• Runny Nose• Itchy, Watery Eyes• Itchy Throat or Nose
*When taken as directed. See Drug Facts Panel.
†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.
* Please review the disclaimer below.