Anti-diarrheal/anti-gas Tablet
FDA Label NDC 69256-265

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Harris Teeter, Llc for the product Anti-diarrheal/anti-gas (NDC 69256-265). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each caplet), purpose, use(s), warnings, do not use, ask a doctor before use if the child has, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Caplet)

Loperamide HCl 2 mg

Simethicone 125 mg


Purpose

Anti-diarrheal

Anti-gas

Use(S)

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

Do Not Use

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

Ask A Doctor Before Use If The Child Has

  • 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.

When Using This Product

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

Stop Use And Ask 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)

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 10 mL 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


Questions Or Comments

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

Principal Display Panel

Harris Teeter™


NDC 69256-265-31

 

MULTI-SYMPTOM RELIEF

 

ANTI-DIARRHEAL/ANTI-GAS

 


Loperamide Hydrochloride and Simethicone

Tablets, 2 mg/125 mg

 

Relieves Symptoms of Diarrhea Plus

Cramps & Pressure

Bloating, Gas


Compare to the active ingredients in Imodium®

Multi-Symptom Relief Caplet*


12 Caplets**

**Capsule-Shaped Tablets

263-12-ht.jpg (263 12 Ht)

263-12-ht.jpg (263 12 Ht)


Harris Teeter™


NDC 69256-265-73

MULTI-SYMPTOM RELIEF

ANTI-DIARRHEAL/ANTI-GAS


Loperamide Hydrochloride and Simethicone

Tablets, 2 mg/125 mg

Relieves Symptoms of Diarrhea Plus

Cramps & Pressure

Bloating, Gas


Compare to the active ingredients in Imodium®

Multi-Symptom Relief Caplet*


18 Caplets**

**Capsule-Shaped Tablets


 

263-18-ht.jpg (263 18 Ht)

263-18-ht.jpg (263 18 Ht)



Harris Teeter™


NDC 69256-265-33

MULTI-SYMPTOM RELIEF

ANTI-DIARRHEAL/ANTI-GAS


Loperamide Hydrochloride and Simethicone

Tablets, 2 mg/125 mg

Relieves Symptoms of Diarrhea Plus

Cramps & Pressure

Bloating, Gas


Compare to the active ingredients in Imodium®

Multi-Symptom Relief Caplet*


24 Caplets**

**Capsule-Shaped Tablets


263-24-ht.jpg (263 24 Ht)

263-24-ht.jpg (263 24 Ht)


* Please review the disclaimer below.