drug facts

Composition & Product

Active Ingredients

loratadine (10 mg)

Inactive Ingredients

fd&c blue no. 1 gelatin glycerin hypromelloses hydrolysed bovine collagen (enzymatic; 2000-5000 mw) isopropyl alcohol mannitol propylene glycol water sorbitan sorbitol titanium dioxide

Identifiers & Packaging

Marketing Status

anda active Since 2019-03-01

Medication Information

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 capsule daily; not more than 1 capsule in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other Information

Tamper-evident: do not use if foil seal under cap, printed with “Sealed for your protection” is missing, open or broken. (For Bottle Labels and Cartons)
Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn. (For Blister Carton)
store between 20° to 25°C (68° to 77°F)
protect from freezing

Inactive Ingredients

FD&C blue no.1, gelatin, glycerin, hypromellose, hydrolyzed collagen, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Description

Loratadine 10 mg

Principal Display Panel

NDC 69452-211-03

Compare to the active ingredient in Claritin^® Liqui-Gels^®**

Original Prescription Strenght

Non-Drowsy*

Loratadine Capsules, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 hour

Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

5 LIQUID-FILLED CAPSULES

*When taken as directed. See Drug Facts Panel

Do not use if carton is open, or if foil inner seal on bottle is broken

Section 42229-5

**This product in not manufactured or distributed by Bayer, owner of the registered trademark Claritin^® and Catalent Pharma Solutions, Inc, owner of the registered trademark LIQUI-GELS^®.

Manufactured for:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540

Rev # 07/17

Do Not Use

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

Questions Or Comments?

1-888-235-2466

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.

Active Ingredient (in Each Capsule)

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 capsule daily; not more than 1 capsule 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)

Tamper-evident: do not use if foil seal under cap, printed with “Sealed for your protection” is missing, open or broken. (For Bottle Labels and Cartons)
Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn. (For Blister Carton)
store between 20° to 25°C (68° to 77°F)
protect from freezing

Inactive Ingredients (Inactive ingredients)

FD&C blue no.1, gelatin, glycerin, hypromellose, hydrolyzed collagen, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Principal Display Panel

NDC 69452-211-03

Compare to the active ingredient in Claritin^® Liqui-Gels^®**

Original Prescription Strenght

Non-Drowsy*

Loratadine Capsules, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 hour

Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

5 LIQUID-FILLED CAPSULES

*When taken as directed. See Drug Facts Panel

Do not use if carton is open, or if foil inner seal on bottle is broken

Section 42229-5 (42229-5)

**This product in not manufactured or distributed by Bayer, owner of the registered trademark Claritin^® and Catalent Pharma Solutions, Inc, owner of the registered trademark LIQUI-GELS^®.

Manufactured for:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540

Rev # 07/17

Do Not Use (Do not use)

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

Questions Or Comments? (Questions or comments?)

1-888-235-2466

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.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

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

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW)", "unii": "5WE8P977RQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "**This product in not manufactured or distributed by Bayer, owner of the registered trademark Claritin ® and Catalent Pharma Solutions, Inc, owner of the registered trademark LIQUI-GELS ® . Manufactured for: Bionpharma Inc. 600 Alexander Road, Princeton, NJ 08540 Rev # 07/17", "Purpose": "Antihistamine", "Directions": "adults and children 6 years and over 1 capsule daily; not more than 1 capsule 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. (For Bottle Labels and Cartons) Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn. (For Blister Carton) store between 20° to 25°C (68° to 77°F) protect from freezing", "Inactive ingredients": "FD&C blue no.1, gelatin, glycerin, hypromellose, hydrolyzed collagen, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide", "Questions or comments?": "1-888-235-2466", "Principal Display Panel": "NDC 69452-211-03 Compare to the active ingredient in Claritin ® Liqui-Gels ®** Original Prescription Strenght Non-Drowsy* Loratadine Capsules, 10 mg Antihistamine Indoor & Outdoor Allergies 24 hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 5 LIQUID-FILLED CAPSULES *When taken as directed. See Drug Facts Panel Do not use if carton is open, or if foil inner seal on bottle is broken", "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.", "Active ingredient (in each capsule)": "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."}

drug facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information