Sam’s West, Inc. Aller-itin™ Drug Facts

Sam’s West, Inc. Aller-itin™ Drug Facts
SPL v2
SPL
SPL Set ID 466cfc50-59d0-47c7-80c7-e113bbf3e748
Route
ORAL
Published
Effective Date 2020-07-13
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 2020-07-13

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
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
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

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

Questions Or Comments?

1-800-809-0469

Principal Display Panel

Compare to Claritin® active ingredient

Original Prescription Strength

Aller-itin™

Loratadine Tablets 10mg/Antihistamine

Indoor & Outdoor Allergies

24 hour relief of:

Sneezing

Runny nose

Itchy, watery eyes

Itchy throat or nose

Non-Drowsy*

*When taken as directed.

See drug facts panel.

actual size

400 Tablets

400 days of relief

Contains 2 bottles with 200 tablets each

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)

Active Ingredient (in Each Tablet)

Loratadine 10 mg

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

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

Do Not Use (Do not use)

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

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

Questions Or Comments? (Questions or comments?)

1-800-809-0469

Principal Display Panel

Compare to Claritin® active ingredient

Original Prescription Strength

Aller-itin™

Loratadine Tablets 10mg/Antihistamine

Indoor & Outdoor Allergies

24 hour relief of:

Sneezing

Runny nose

Itchy, watery eyes

Itchy throat or nose

Non-Drowsy*

*When taken as directed.

See drug facts panel.

actual size

400 Tablets

400 days of relief

Contains 2 bottles with 200 tablets each

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)

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Loratadine 10 mg

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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