ANTIDIARRHEAL MULTI SYMPTOM RELIEF- loperamide hydrochloride, simethicone tablet

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)

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 MULTI SYMPTOM RELIEF
loperamide hydrochloride, simethicone tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209837	08/03/2020

Labeler - Publix Super Markets Inc (006922009)

antidiarrheal multi symptom relief by