Loratadine Tablets, 10 Mg

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 2020-09-11

Medication Information

Purpose

Antihistamine

Description

Loratadine 10 mg

Uses

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

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

Active Ingredient

Loratadine 10 mg

Other Information

Tamper-evident: do not use if foil under cap is missing, open or broken
store between 20º to 25ºC (68º to 77ºF)

Inactive Ingredients

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

Principal Display Panel

Compare to the active ingredient in Claritin®†

NON-DROWSY*

Original Prescription Strength

Loratadine Tablets, 10 mg / Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose

365 Tablets

*When taken as directed

See Drug Facts Panel

†This product is not manufactured or distributed by Bayer Healthcare, LLC, owner of the registered trademark Claritin®.

When Usung This Product

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

Questions Or Comments?

1-888-333-9792

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 A 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.

If Pregnant Or Breast Feeding,

ask a health professional before use

Structured Label Content

Uses

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

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

Active Ingredient (Active ingredient)

Loratadine 10 mg

Other Information (Other information)

Tamper-evident: do not use if foil under cap is missing, open or broken
store between 20º to 25ºC (68º to 77ºF)

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to the active ingredient in Claritin®†

NON-DROWSY*

Original Prescription Strength

Loratadine Tablets, 10 mg / Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose

365 Tablets

*When taken as directed

See Drug Facts Panel

†This product is not manufactured or distributed by Bayer Healthcare, LLC, owner of the registered trademark Claritin®.

When Usung This Product (When usung this product)

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

Questions Or Comments? (Questions or comments? )

1-888-333-9792

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 A Doctor If (Stop use and ask a 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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Advanced Ingredient Data

[{"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "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": "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": "if you have ever had an allergic reaction to this product or any of its ingredients", "Active ingredient": "Loratadine 10 mg", "Other information": "Tamper-evident: do not use if foil under cap is missing, open or broken store between 20º to 25ºC (68º to 77ºF)", "Inactive ingredients": "Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized", "PRINCIPAL DISPLAY PANEL": "Compare to the active ingredient in Claritin®† NON-DROWSY* Original Prescription Strength Loratadine Tablets, 10 mg / Antihistamine Indoor & Outdoor Allergies 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 365 Tablets *When taken as directed See Drug Facts Panel †This product is not manufactured or distributed by Bayer Healthcare, LLC, owner of the registered trademark Claritin®.", "When usung this product": "do not take more than directed. Taking more than directed may cause drowsiness.", "Questions or comments? ": "1-888-333-9792", "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 a 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.", "If pregnant or breast-feeding,": "ask a health professional before use"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information