Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID bc253aa7-686c-40e6-affa-a585b465046a
Route
ORAL
Published
Effective Date 2013-12-03
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 2013-12-03

Description

Loratadine, USP 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

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
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
Do Not Use

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

Questions?

Call 1-877-932-7948

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, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor

Principal Display Panel

equaline ®

compare to Claritin ® RediTabs ® active ingredient **

NDC 41163-528-69

original prescription strength

melts in your mouth

allergy relief

loratadine orally disintegrating tablets, USP 10 mg

antihistamine

no water needed

indoor and outdoor allergies

non-drowsy* 24 hour relief of:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itchy throat or nose

10 orally disintegrating tablets

* When taken as directed. See Drug Facts Panel.

DISTRIBUTED BY SUPERVALU INC.

5105058/ R0913

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, USP 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 (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
Do Not Use

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

Questions? (QUESTIONS?)

Call 1-877-932-7948

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, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

equaline ®

compare to Claritin ® RediTabs ® active ingredient **

NDC 41163-528-69

original prescription strength

melts in your mouth

allergy relief

loratadine orally disintegrating tablets, USP 10 mg

antihistamine

no water needed

indoor and outdoor allergies

non-drowsy* 24 hour relief of:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itchy throat or nose

10 orally disintegrating tablets

* When taken as directed. See Drug Facts Panel.

DISTRIBUTED BY SUPERVALU INC.

5105058/ R0913

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, USP 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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