Loratadine Tablets, 10 Mg

Loratadine Tablets, 10 Mg
SPL v3
SPL
SPL Set ID bd6cd66b-1144-4d0b-b13a-230590b398e4
Route
ORAL
Published
Effective Date 2023-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Lactose Monohydrate Starch, Corn Povidone Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: P;10 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2021-06-27
Description

Loratadine 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Loratadine 10 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  •  runny nose
  •  sneezing
  • itchy, water eyes 
  •  itching of the nose or throat
Section 42229-5

Manufactured by:

Unique Pharmaceutical Laboratories

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India.

Distributed by:

Drug Ocean LLC

1 Bridge Plaza, North Central Road,

6th Floor, Suite 675, Fort Lee, NJ 07024

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

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients

Display Panel

NON-DROWSY* 24 Hour

Loratadine Tablets, USP

Indoor and Outdoor Allergies

10mg

Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy, Nose or Throat

*When taken as directed.

See Drug Facts Panel.

100 Tablets

Active Ingredient

Loratadine 10 mg

Other Information
  • Tamper-evident: do not use if foil under cap is missing, open or broken
  • store between 20º to 25ºC (68º to 77ºF)

Inactive Ingredients

Lactose monohydrate, magnesium stearate, povidone, starch maize pregelatinized

When Usung This Product

do not take more than directed. Taking more than directed may cause drowsiness.

Questions Or Comments? 

1-844-200-6566 Monday to Friday 9 AM to 5 PM EST

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 A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

ask a health professional before use

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  •  runny nose
  •  sneezing
  • itchy, water eyes 
  •  itching of the nose or throat
Section 42229-5 (42229-5)

Manufactured by:

Unique Pharmaceutical Laboratories

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai 400 030, India.

Distributed by:

Drug Ocean LLC

1 Bridge Plaza, North Central Road,

6th Floor, Suite 675, Fort Lee, NJ 07024

Purpose

Antihistamine

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

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients

Display Panel (DISPLAY PANEL)

NON-DROWSY* 24 Hour

Loratadine Tablets, USP

Indoor and Outdoor Allergies

10mg

Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy, Nose or Throat

*When taken as directed.

See Drug Facts Panel.

100 Tablets

Active Ingredient (Active ingredient)

Loratadine 10 mg

Other Information (Other information)
  • Tamper-evident: do not use if foil under cap is missing, open or broken
  • store between 20º to 25ºC (68º to 77ºF)

Inactive Ingredients (Inactive ingredients)

Lactose monohydrate, magnesium stearate, povidone, starch maize pregelatinized

When Usung This Product (When usung this product)

do not take more than directed. Taking more than directed may cause drowsiness.

Questions Or Comments?  (Questions or comments? )

1-844-200-6566 Monday to Friday 9 AM to 5 PM EST

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 A 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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:34.466899 · Updated: 2026-03-14T23:01:28.904310