loratadine tablets usp 10mg
3360d02d-612d-4cc5-acc9-2cc93713c387
34390-5
Human OTC Drug Label
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Purpose Antihistamine
Description
Active ingredient (in each tablet) Loratadine USP, 10 mg
Medication Information
Warnings
Warnings
Purpose
Purpose
Antihistamine
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 |
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Description
Active ingredient (in each tablet) Loratadine USP, 10 mg
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
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
Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Active Ingredient(s)
Active ingredient (in each tablet)
Loratadine USP, 10 mg
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
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 20º to 25º C (68º to 77º F)
- FDA approved dissolution test specifications differ from USP
Pregnancy/breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
When Using This Product
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
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.
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.
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).
Structured Label Content
Warnings (WARNINGS)
Warnings
Purpose (PURPOSE)
Purpose
Antihistamine
Directions (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 |
Inactive Ingredients (Inactive ingredients)
Inactive ingredients colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Principal Display Panel (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
Use(s) (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
Do Not Use (DO NOT USE)
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Active Ingredient(s) (ACTIVE INGREDIENT(S))
Active ingredient (in each tablet)
Loratadine USP, 10 mg
Questions Or Comments? (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
Other Required Warnings (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 20º to 25º C (68º to 77º F)
- FDA approved dissolution test specifications differ from USP
Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)
If pregnant or breast-feeding, ask a health professional before use.
When Using This Product (WHEN USING THIS PRODUCT)
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Ask A Doctor Before Use If (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.
Stop Use and Ask Doctor If (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.
Keep Out of Reach of Children (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).
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:32.337540 · Updated: 2026-03-14T23:05:21.514130