topcare anti diarrheal anti gas

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 2 mg

Simethicone 125 mg

Purposes

OTC - PURPOSE SECTION

Anti-diarrheal

Anti-gas

Uses

INDICATIONS & USAGE SECTION

relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Warnings

WARNINGS SECTION

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Heart alert: Taking more than directed can cause serious heart problems or death

Do not use

OTC - DO NOT USE SECTION

• if you have bloody or black stool
• if you have difficulty swallowing

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• fever
• mucus in the stool
• a history of liver disease
• a history of abnormal heart rhythm

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug. Loperamide may interact with certain prescription drugs.

When using this product

OTC - WHEN USING SECTION

tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• symptoms get worse
• diarrhea lasts for more than 2 days
• you get abdominal swelling or bulging. These may be signs of a serious condition.
• you have difficulty swallowing the caplet

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

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• take only on an empty stomach (1 hour before or 2 hours after a meal)
• take with a full (8 oz.) glass of water
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.

adults and children 12 years and over	2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs)	1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs)	1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children 2-5 years (34 to 47 lbs)	ask a doctor
children under 2 years (up to 33 lbs)	do not use

Other information

STORAGE AND HANDLING SECTION

• each caplet contains: calcium 165 mg, sodium 3 mg
• store between 20^°-25^°C (68^°-77^°F). Protect from light.
• do not use if printed blister unit is broken or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, maltodextrin, microcrystalline cellulose, natural and artificial flavor, propylene glycol, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare^® health

COMPARE TO IMODIUM^® MULTI-SYMPTOM RELIEF ACTIVE INGREDIENTS

Anti-Diarrheal

Anti-Gas

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLETS, 2 mg/125 mg

ANTI-DIARRHEAL/ANTI-GAS

MULTI-SYMPTOM RELIEF CAPLET

Relieves symptoms of diarrhea plus

• Cramps & Pressure

• Bloating

• Gas

24 CAPLETS†

†CAPSULE-SHAPED TABLETS

actual size

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Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

• topcare anti diarrheal anti gas
• loperamide hydrochloride, simethicone
• LOPERAMIDE HYDROCHLORIDE
• LOPERAMIDE
• DIMETHICONE
• SILICON DIOXIDE
• ACESULFAME POTASSIUM
• CROSCARMELLOSE SODIUM
• ANHYDROUS DIBASIC CALCIUM PHOSPHATE
• MALTODEXTRIN
• MICROCRYSTALLINE CELLULOSE
• PROPYLENE GLYCOL
• STEARIC ACID

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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Source XML

Orange Book application contexts#

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

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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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Reported adverse events (FAERS/openFDA)#

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