Equate Anti-diarrheal/anti-gas Multi-symptom Relief

Equate Anti-diarrheal/anti-gas Multi-symptom Relief
SPL v2
SPL
SPL Set ID 23af573f-8d40-6b82-e063-6394a90aabab
Route
ORAL
Published
Effective Date 2024-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 2;63 Shape: capsule Color: white Size: 16 mm Score: 2
Marketing Status
ANDA Active Since 2024-11-01

Description

Loperamide HCl 2 mg Simethicone 125 mg

Purpose

Anti-diarrheal Anti-gas


Medication Information

Purpose

Anti-diarrheal

Anti-gas

Description

Loperamide HCl 2 mg Simethicone 125 mg

Use(s)

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

Section 42229-5

DISTRIBURED BY: Walmart Inc.,

Bentonville, AR 72716

PRODUCT OF INDIA

**This product is not manufactured or distributed by Johnson and Johnson Consumer Inc. • McNeil Consumer Healthcare, owner of the registered trademark Imodium ® Multi-Symptom Relief.

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 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

Do Not Use
  • if you have bloody or black stool
  • if you have difficulty swallowing
Other Information

  • each caplet contains: calcium 180 mg, sodium 3 mg
  • store between 20-25°C (68-77°F). Protect from light
  • do not use if blister unit is torn or broken.
Active Ingredients

Loperamide HCl 2 mg

Simethicone 125 mg

Inactive Ingredients

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

Questions Or Comments?

call 1-609-860-2600 (Monday - Friday 8 am - 4 pm)

Principal Display Panel

NDC 79903-302-12

equate™

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.

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)

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

Use(s)

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

Section 42229-5 (42229-5)

DISTRIBURED BY: Walmart Inc.,

Bentonville, AR 72716

PRODUCT OF INDIA

**This product is not manufactured or distributed by Johnson and Johnson Consumer Inc. • McNeil Consumer Healthcare, owner of the registered trademark Imodium ® Multi-Symptom Relief.

Purpose

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 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

Do Not Use (Do not use)
  • if you have bloody or black stool
  • if you have difficulty swallowing
Other Information (Other information)

  • each caplet contains: calcium 180 mg, sodium 3 mg
  • store between 20-25°C (68-77°F). Protect from light
  • do not use if blister unit is torn or broken.
Active Ingredients (Active ingredients)

Loperamide HCl 2 mg

Simethicone 125 mg

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

call 1-609-860-2600 (Monday - Friday 8 am - 4 pm)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 79903-302-12

equate™

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.

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 (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)

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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