Loperamide Hydrochloride And Simethicone Tablets, 2 Mg/125 Mg

Loperamide Hydrochloride And Simethicone Tablets, 2 Mg/125 Mg
SPL v3
SPL
SPL Set ID e0c1693e-0e55-4368-a8a5-2f0882fbf952
Route
ORAL
Published
Effective Date 2022-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (2 mg) Dimethicone (125 mg)
Inactive Ingredients
Microcrystalline Cellulose Croscarmellose Sodium Acesulfame Potassium Stearic Acid Anhydrous Dibasic Calcium Phosphate Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: I;9 Shape: capsule Color: white Size: 17 mm Score: 2
Marketing Status
ANDA Active Since 2023-03-01

Description

Drug Facts

Purpose

Anti-diarrheal Anti-gas


Medication Information

Purpose

Anti-diarrheal Anti-gas

Description

Drug Facts

Uses

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

Purposes

Anti-diarrheal

Anti-gas

Warnings

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



Directions
  • 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 ag
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

  • each caplet contains: calcium 148.40 mg, sodium 1.40 mg
  • store between 20-25°C (68-77°F). Protect from light.
  • for blister: do not use if blister unit is torn or broken
Do Not Use
  • if you have bloody or black stool
  • if you have difficulty swallowing
Inactive Ingredients

acesulfame potassium, anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, flavor, microcrystalline cellulose, stearic acid.





Questions or comments?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST



Manufactured by:



Granules India Limited



Hyderabad-500 081, INDIA



MADE IN INDIA

Principal Display Panel

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

12 Caplets *

*capsule-shaped tablets

When Using This Product

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



Spl Unclassified Section

Drug Facts

Stop Use and Ask A Doctor If
  • 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, 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 Caplet)

Loperamide HCl, 2 mg



Simethicone, 125 mg

Ask a doctor Before Use If You Have
  • 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

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




Structured Label Content

Uses

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

Purposes

Anti-diarrheal

Anti-gas

Warnings

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



Directions
  • 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 ag
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

  • each caplet contains: calcium 148.40 mg, sodium 1.40 mg
  • store between 20-25°C (68-77°F). Protect from light.
  • for blister: do not use if blister unit is torn or broken
Do Not Use (Do not use)
  • if you have bloody or black stool
  • if you have difficulty swallowing
Inactive Ingredients

acesulfame potassium, anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, flavor, microcrystalline cellulose, stearic acid.





Questions or comments?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST



Manufactured by:



Granules India Limited



Hyderabad-500 081, INDIA



MADE IN INDIA

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

12 Caplets *

*capsule-shaped tablets

When Using This Product (When using this product)

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



Spl Unclassified Section (SPL UNCLASSIFIED SECTION)

Drug Facts

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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, 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 Caplet) (Active ingredients (in each caplet))

Loperamide HCl, 2 mg



Simethicone, 125 mg

Ask a doctor Before Use If You Have (Ask a doctor before use if you have)
  • 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 (Ask a doctor or pharmacist before use if you are)

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




Advanced Ingredient Data


Raw Label Data

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