Anti Diarrheal Anti Gas Tablet
FDA Label NDC 37808-714

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Anti Diarrheal Anti Gas (NDC 37808-714). 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), purposes, uses, warnings, do not use, ask a doctor before use if you have, 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

Purposes

Anti-diarrheal

Anti-gas

Uses

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 You Have

  • fever
  • mucus in the stool
  • a history of liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking antibiotics

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)

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 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

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

Questions Or Comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Imodium® Multi-Symptom Relief active ingredients

See New Warning and Directions

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

actual size

12 CAPLETS*

*Capsule-Shaped Tablets

* Please review the disclaimer below.