topcare allergy and congestion relief

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 5 mg

Pseudoephedrine sulfate 120 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• 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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• 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.

When using this product do not take more than directed.

OTC - WHEN USING SECTION

Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

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

adults and children 12 years and over	1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

STORAGE AND HANDLING SECTION

• each tablet contains: calcium 25 mg
• do not use if blister unit is broken or torn
• store between 20° to 25°C (68° to 77°F)
• keep in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare_® health

COMPARE TO CLARITIN-D^® 12 HOUR EXTENDED RELEASE TABLETS ACTIVE INGREDIENTS

NON-DROWSY*

Allergy & Congestion Relief

PSEUDOEPHEDRINE SULFATE 120 mg • LORATADINE 5 mg EXTENDED RELEASE TABLETS

NASAL DECONGESTANT • ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

12 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

30 EXTENDED RELEASE TABLETS

*When taken as directed. See Drug Facts Panel.

actual size

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

• topcare allergy and congestion relief
• loratadine, pseudoephedrine sulfate
• LORATADINE
• PSEUDOEPHEDRINE SULFATE
• PSEUDOEPHEDRINE
• CROSCARMELLOSE SODIUM
• ANHYDROUS DIBASIC CALCIUM PHOSPHATE
• HYPROMELLOSE, UNSPECIFIED
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• POVIDONE, UNSPECIFIED
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.