Label: ANTI-DIARRHEAL/ANTI-GAS- loperamide hydrochloride, simethicone tablet
- NDC Code(s): 69256-265-31, 69256-265-33, 69256-265-73
- Packager: Harris Teeter, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 5, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
- STOP USE AND ASK DOCTOR IF
- IF PREGNANT OR BREAST FEEDING,
- KEEP OUT OF REACH OF CHILDREN
-
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
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
-
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
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
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
-
INGREDIENTS AND APPEARANCE
ANTI-DIARRHEAL/ANTI-GAS
loperamide hydrochloride, simethicone tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69256-265 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 2 mg DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 125 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score 2 pieces Shape CAPSULE Size 16mm Flavor CARAMEL Imprint Code 2;63 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69256-265-31 2 in 1 CARTON 02/05/2025 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:69256-265-73 3 in 1 CARTON 02/05/2025 2 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:69256-265-33 4 in 1 CARTON 02/05/2025 3 6 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214541 02/05/2025 Labeler - Harris Teeter, LLC (048463103) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 MANUFACTURE(69256-265)