ANTIDIARRHEAL MULTI SYMPTOM RELIEF- loperamide hydrochloride, simethicone tablet 
Publix Super Markets Inc

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Publix Super Markets, Inc. Antidiarrheal Multi-Symptom Relief Drug Facts

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
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 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 68°-77°F (20°-25°C). 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

Package/Label Principal Display Panel

antidiarrheal multi-symptom relief

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLETS, 2 mg/125 mg

ANTI-DIARRHEAL /ANTI-GAS

Relieves symptoms of diarrhea plus:

Cramps & pressure

Bloating

Gas

ACTUAL SIZE

24 CAPLETS*

*CAPSULE-SHAPED TABLETS

Compare to Imodium® Multi-Symptom Relief active ingredients

antidiarrheal image
ANTIDIARRHEAL MULTI SYMPTOM RELIEF 
loperamide hydrochloride, simethicone tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-511
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore2 pieces
ShapeOVALSize17mm
FlavorImprint Code L0R1;2;125
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56062-511-6224 in 1 CARTON08/03/2020
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20983708/03/2020
Labeler - Publix Super Markets Inc (006922009)

Revised: 8/2020
Document Id: 37b3e1b3-2c85-45ae-959d-9d33c5c9d685
Set id: addb2c44-bab0-430a-8305-281f30a66d87
Version: 2
Effective Time: 20200806
 
Publix Super Markets Inc