Loratadine Tablets, 10 Mg

Loratadine Tablets, 10 Mg
SPL v1
SPL
SPL Set ID b0c64c16-3c05-e8e6-e053-2a95a90a533c
Route
ORAL
Published
Effective Date 2017-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Lactose Monohydrate Starch, Corn Magnesium Stearate Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: G;10 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2020-01-01

Description

Loratadine 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Loratadine 10 mg

Use(s)

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

Storage

store between 20º to 25ºC (68º to 77ºF)

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

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken



Blister Foil Units



safety sealed: do not use if the individual blister unit is open or torn

Active Ingredient(s)

Loratadine 10 mg

Inactive Ingredients

Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

Questions Or Comments

Contact 1-844-384-3723 Mon-Fri 9:00 AM to 4:30 PM EST.

Pregnancy/breastfeeding

ask a health professional before use

Principal Display Panel

When Using This Product

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

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 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.


Structured Label Content

Use(s) (USE(S))

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

Purpose (PURPOSE)

Antihistamine

Storage (STORAGE)

store between 20º to 25ºC (68º to 77ºF)

Directions (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)

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken



Blister Foil Units



safety sealed: do not use if the individual blister unit is open or torn

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Loratadine 10 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

Questions Or Comments (QUESTIONS OR COMMENTS)

Contact 1-844-384-3723 Mon-Fri 9:00 AM to 4:30 PM EST.

Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)

ask a health professional before use

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (WHEN USING THIS PRODUCT)

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

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 Doctor If (STOP USE AND ASK 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.


Advanced Ingredient Data


Raw Label Data

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