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

Purpose

Anti-diarrheal Anti-gas

Description

Loperamide HCl 2 mg Simethicone 125 mg


Medication Information

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

Purpose

Anti-diarrheal

Anti-gas

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

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.
Inactive Ingredients

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

Description

Loperamide HCl 2 mg Simethicone 125 mg

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

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.

Do Not Use
  • if you have bloody or black stool
  • if you have difficulty swallowing
Active Ingredients

Loperamide HCl 2 mg

Simethicone 125 mg

Questions Or Comments?

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

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

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

Purpose

Anti-diarrheal

Anti-gas

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

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.
Inactive Ingredients (Inactive ingredients)

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

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

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.

Do Not Use (Do not use)
  • if you have bloody or black stool
  • if you have difficulty swallowing
Active Ingredients (Active ingredients)

Loperamide HCl 2 mg

Simethicone 125 mg

Questions Or Comments? (Questions or comments?)

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

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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