Topco Associates Llc. Allergy & Congestion Relief Drug Facts

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg) Pseudoephedrine (240 mg)

Inactive Ingredients

Silicon Dioxide Ferric Oxide Red Hypromellose, Unspecified Magnesium Stearate Polyethylene Glycol, Unspecified Propylene Glycol Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Shape: oval Color: white Size: 19 mm Score: 1

Marketing Status

ANDA Active Since 2023-08-16

Medication Information

Purpose

Antihistamine

Nasal decongestant

Description

Loratadine 10 mg Pseudoephedrine sulfate 240 mg

Uses

•
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
•
sneezing
•
itchy, watery eyes
•
runny nose
•
itching of the nose or throat
•
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
•
reduces swelling of nasal passages
•
temporarily relieves sinus congestion and pressure

temporarily restores freer breathing through the nose

Directions

•
do not divide, crush, chew or dissolve the tablet

adults and children 12 years and over	1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
children under 12 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
•
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Other Information

•
do not use if printed blister unit is broken or torn
•
store between 20°-25°C (68°-77°F)
•
protect from light and store in a dry place

Inactive Ingredients

colloidal silicon dioxide, ferric oxide, hydrogenated vegetable oil, hypromellose, magnesium stearate, polyethylene glycol, polyethylene oxide, propylene glycol, titanium dioxide

Questions Or Comments?

1-888-423-0139

Stop Use and Ask A Doctor If

•
an allergic reaction to this product occurs. Seek medical help right away.
•
symptoms do not improve within 7 days or are accompanied by a fever
•
nervousness, dizziness or sleeplessness occurs

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 Ingredients (in Each Tablet)

Loratadine 10 mg

Pseudoephedrine sulfate 240 mg

Ask A Doctor Before Use If You Have

•
heart disease
•
thyroid disease
•
high blood pressure
•
diabetes
•
trouble urinating due to an enlarged prostate gland
•
liver or kidney disease. Your doctor should determine if you need a different dose.

Package/label Principal Display Panel

TopCare_® health

COMPARE TO CLARITIN-D^® 24 HOUR EXTENDED RELEASE TABLETS

ACTIVE INGREDIENTS

NON-DROWSY*

Allergy & Congestion Relief

PSEUDOEPHEDRINE SULFATE 240 mg • LORATADINE 10 mg EXTENDED RELEASE TABLETS

NASAL DECONGESTANT • ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

• Nasal and Sinus Congestion Due to Colds or Allergies

• Sneezing • Runny Nose • Itchy, Watery Eyes

• Itchy Throat or Nose Due to Allergies

15 EXTENDED RELEASE TABLETS

*When taken as directed. See Drug Facts Panel.

actual size

When Using This Product Do Not Take More Than Directed.

Taking more than directed may cause drowsiness.

Structured Label Content

Uses

•
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
•
sneezing
•
itchy, watery eyes
•
runny nose
•
itching of the nose or throat
•
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
•
reduces swelling of nasal passages
•
temporarily relieves sinus congestion and pressure

temporarily restores freer breathing through the nose

Purpose

Antihistamine

Nasal decongestant

Directions

•
do not divide, crush, chew or dissolve the tablet

adults and children 12 years and over	1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
children under 12 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
•
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Other Information (Other information)

•
do not use if printed blister unit is broken or torn
•
store between 20°-25°C (68°-77°F)
•
protect from light and store in a dry place

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, ferric oxide, hydrogenated vegetable oil, hypromellose, magnesium stearate, polyethylene glycol, polyethylene oxide, propylene glycol, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-423-0139

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.
•
symptoms do not improve within 7 days or are accompanied by a fever
•
nervousness, dizziness or sleeplessness occurs

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 Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Loratadine 10 mg

Pseudoephedrine sulfate 240 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

•
heart disease
•
thyroid disease
•
high blood pressure
•
diabetes
•
trouble urinating due to an enlarged prostate gland
•
liver or kidney disease. Your doctor should determine if you need a different dose.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

TopCare_® health

COMPARE TO CLARITIN-D^® 24 HOUR EXTENDED RELEASE TABLETS

ACTIVE INGREDIENTS

NON-DROWSY*

Allergy & Congestion Relief

PSEUDOEPHEDRINE SULFATE 240 mg • LORATADINE 10 mg EXTENDED RELEASE TABLETS

NASAL DECONGESTANT • ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

• Nasal and Sinus Congestion Due to Colds or Allergies

• Sneezing • Runny Nose • Itchy, Watery Eyes

• Itchy Throat or Nose Due to Allergies

15 EXTENDED RELEASE TABLETS

*When taken as directed. See Drug Facts Panel.

actual size

When Using This Product Do Not Take More Than Directed. (When using this product do not take more than directed.)

Taking more than directed may cause drowsiness.

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "240", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "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: • sneezing • itchy, watery eyes • runny nose • itching of the nose or throat • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose", "Purpose": "Antihistamine Nasal decongestant", "Directions": "• do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 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 • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.", "Other information": "• do not use if printed blister unit is broken or torn • store between 20°-25°C (68°-77°F) • protect from light and store in a dry place", "Inactive ingredients": "colloidal silicon dioxide, ferric oxide, hydrogenated vegetable oil, hypromellose, magnesium stearate, polyethylene glycol, polyethylene oxide, propylene glycol, titanium dioxide", "Questions or comments?": "1-888-423-0139", "Stop use and ask a doctor if": "• an allergic reaction to this product occurs. Seek medical help right away. • symptoms do not improve within 7 days or are accompanied by a fever • nervousness, dizziness or sleeplessness occurs", "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 ingredients (in each tablet)": "Loratadine 10 mg Pseudoephedrine sulfate 240 mg", "Ask a doctor before use if you have": "• heart disease • thyroid disease • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose.", "Package/Label Principal Display Panel": "TopCare ® health COMPARE TO CLARITIN-D ® 24 HOUR EXTENDED RELEASE TABLETS ACTIVE INGREDIENTS NON-DROWSY* Allergy & Congestion Relief PSEUDOEPHEDRINE SULFATE 240 mg • LORATADINE 10 mg EXTENDED RELEASE TABLETS NASAL DECONGESTANT • ANTIHISTAMINE INDOOR & OUTDOOR ALLERGIES 24 HOUR RELIEF OF: • Nasal and Sinus Congestion Due to Colds or Allergies • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose Due to Allergies 15 EXTENDED RELEASE TABLETS *When taken as directed. See Drug Facts Panel. actual size", "When using this product do not take more than directed.": "Taking more than directed may cause drowsiness."}

Topco Associates Llc. Allergy & Congestion Relief Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information