Label: ANTIDIARRHEAL MULTI SYMPTOM RELIEF- loperamide hydrochloride, simethicone tablet
- NDC Code(s): 56062-511-62
- Packager: Publix Super Markets Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated August 6, 2020
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- Official Label (Printer Friendly)
- 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
- 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 9-11 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
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
ANTIDIARRHEAL MULTI SYMPTOM RELIEF
loperamide hydrochloride, simethicone tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-511 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 17mm Flavor Imprint Code L0R1;2;125 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56062-511-62 24 in 1 CARTON 08/03/2020 1 1 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 ANDA209837 08/03/2020 Labeler - Publix Super Markets Inc (006922009)