FDA Label for Loratadine 10mg
View Indications, Usage & Precautions
Loratadine 10mg Product Label
The following document was submitted to the FDA by the labeler of this product Marksans Pharma Limited. 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.
Active Ingredient(S)
Active ingredient (in each tablet)
Loratadine USP, 10 mg
Purpose
Purpose
Antihistamine
Use(S)
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
Warnings
Warnings
Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Ask A Doctor Before Use If
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
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop Use And Ask Doctor If
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Pregnancy/Breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
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
Directions
| adults and children 6 years and over | 1 tablet daily; not more than 1 tablet in 24 hours |
| children under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other Required Warnings
Other information
- For Bottle pack: Tamper-evident: do not use this product if the imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing.
- For Blister pack: Tamper-evident: do not use if the individual blister unit is open or torn
- store between 20° to 25° C (68° to 77° F)
- FDA approved dissolution test specifications differ from USP
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions Or Comments?
Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735
Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722
Made in India
Principal Display Panel
NDC: 25000-092-81
Loratadine Tablets USP, 10 mg
14's count Carton
NDC: 25000-092-03
Loratadine Tablets USP, 10 mg
30's count Carton
NDC: 25000-092-03
Loratadine Tablets USP, 10 mg
30's count Label
NDC: 25000-092-79
Loratadine Tablets USP, 10 mg
150's count Carton
NDC: 25000-092-79
Loratadine Tablets USP, 10 mg
150's count Label
NDC: 25000-092-80
Loratadine Tablets USP, 10 mg
365's count Label
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