drug facts

drug facts
SPL v1
SPL
SPL Set ID 1fcc897d-bc89-4270-bf03-dc6c2abe1d18
Route
oral
Published
Effective Date 2013-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
loratadine (10 mg)
Inactive Ingredients
aspartame croscarmellose sodium magnesium stearate mannitol sodium stearyl fumarate

Identifiers & Packaging

Pill Appearance
Imprint: RC17 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
anda active Since 2007-08-31

Purpose

Antihistamine

Description

Loratadine, USP 10 mg


Medication Information

Active Ingredient

Loratadine, USP 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
  • place 1 tablet on tongue; tablet disintegrates, with or without water
    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
  • Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
  • keep in a dry place.
  • use tablet immediately after opening individual blister.
Inactive Ingredients

Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

Description

Loratadine, USP 10 mg

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS OF CLARITIN ® REDITABS ®

Best Choice ® Brand

Original Prescription Strength

Non-Drowsy

Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

24 Hour Allergy Relief

ANTIHISTAMINE

No Water Needed

Indoor & Outdoor Allergies

Melts in Your Mouth

For Adults & Children six years & older!

Relief of:

Sneezing; Runny Nose

Itchy, Watery Eyes; Itchy Throat or Nose

10 Orally Disintegrating Tablets

When taken as directed.

See Drug Facts Panel.

DISTRIBUTED BY: VALU MERCHANDISERS, CO.

5079396/R0610

Questions?

call 1-800-406-7984

Do Not Use

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

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, USP 10 mg

Uses (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 (PURPOSE)

Antihistamine

Directions (DIRECTIONS)
  • place 1 tablet on tongue; tablet disintegrates, with or without water
    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)
  • Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
  • keep in a dry place.
  • use tablet immediately after opening individual blister.
Inactive Ingredients (INACTIVE INGREDIENTS)

Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO THE ACTIVE INGREDIENTS OF CLARITIN ® REDITABS ®

Best Choice ® Brand

Original Prescription Strength

Non-Drowsy

Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

24 Hour Allergy Relief

ANTIHISTAMINE

No Water Needed

Indoor & Outdoor Allergies

Melts in Your Mouth

For Adults & Children six years & older!

Relief of:

Sneezing; Runny Nose

Itchy, Watery Eyes; Itchy Throat or Nose

10 Orally Disintegrating Tablets

When taken as directed.

See Drug Facts Panel.

DISTRIBUTED BY: VALU MERCHANDISERS, CO.

5079396/R0610

Questions? (QUESTIONS?)

call 1-800-406-7984

Do Not Use (Do not use)

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

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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