Label: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE tablet
- NDC Code(s): 55319-052-75
- Packager: Family Dollar Stores, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 18, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- 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
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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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 to 11 years (60 to 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 to 8 years (48 to 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 to 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?
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (12 Caplets) Blister Carton Label
FAMILY
Welness™
COMPARE TO THE ACTIVE
INGREDIENTS OF IMODIUM
MULTI-SYMPTON RELIEF**
Multi-Sympton Relief Caplet
ANTI-DIARRHEAL
Loperamide HCl and Simethicone Tablets
2 mg/125 mg
Loperamide HCl 2 mg - Antidiarrheal
Simethicone 125 mg - Anti-gas
Relieves symptoms of diarrhea plus
• Cramps & Pressure
• Bloating
• Gas12 Caplets* ACTUAL SIZE
*CAPSULE-SHAPED TABLETS NDC 55319-052-75
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INGREDIENTS AND APPEARANCE
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
loperamide hydrochloride and simethicone tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-052 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) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE (off-white) Score 2 pieces Shape CAPSULE Size 17mm Flavor VANILLA Imprint Code T;79 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-052-75 2 in 1 CARTON 08/11/2023 1 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 ANDA211059 08/11/2023 Labeler - Family Dollar Stores, LLC (024472631) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650918514 ANALYSIS(55319-052) , MANUFACTURE(55319-052)