perrigo allergy relief drug facts

perrigo allergy relief drug facts
SPL v1
SPL
SPL Set ID 9cc3d50a-81ce-4c9d-9721-209169a332e0
Route
oral
Published
Effective Date 2024-08-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
loratadine (10 mg)
Inactive Ingredients
lactose monohydrate magnesium stearate povidone, unspecified

Identifiers & Packaging

Pill Appearance
Imprint: L612 Shape: oval Color: white Size: 8 mm Score: 1
Marketing Status
anda active Since 2004-09-21

Purpose

Antihistamine

How Supplied

Product: 50090-7051 NDC: 50090-7051-0 90 TABLET in a BOTTLE / 8 in a CASE

Description

Loratadine 10 mg


Medication Information

Active Ingredient

Loratadine 10 mg

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
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

Other Information
  • do not use if printed foil under cap is broken or missing
  • store between 20°to 25°C (68° to 77°F)
Inactive Ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

How Supplied

Product: 50090-7051

NDC: 50090-7051-0 90 TABLET in a BOTTLE / 8 in a CASE

Description

Loratadine 10 mg

Do Not Use

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

Loratadine
Questions Or Comments?

1-800-719-9260

When Using This Product

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

Stop Use and Ask A Doctor If

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

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)

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.


Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Loratadine 10 mg

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
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

Other Information (Other information)
  • do not use if printed foil under cap is broken or missing
  • store between 20°to 25°C (68° to 77°F)
Inactive Ingredients (Inactive ingredients)

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

How Supplied (HOW SUPPLIED)

Product: 50090-7051

NDC: 50090-7051-0 90 TABLET in a BOTTLE / 8 in a CASE

Do Not Use (Do not use)

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

Loratadine
Questions Or Comments? (Questions or comments?)

1-800-719-9260

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 A Doctor If (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding, (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)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver or kidney disease. Your doctor should determine if you need a different dose.


Advanced Ingredient Data


Raw Label Data

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