ANTI DIARRHEAL ANTI GAS- 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
Ask a doctor or pharmacist before use if you are

taking antibiotics
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 20°-25°C (68°-77°F). Protect from light.
- do not use if printed foil under cap is broken or missing
Inactive ingredients

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, maltodextrin, microcrystalline cellulose, natural and artificial flavor, propylene glycol, stearic acid
Questions or comments?

1-800-719-9260
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Compare to Imodium® Multi-Symptom Relief active ingredients

See New Warning and Directions

loperamide hydrochloride and simethicone tablets, 2 mg/125 mg

Anti-Diarrheal/Anti-gas

Multi-Symptom Relief Caplet

Relieves symptoms of diarrhea plus

Cramps & Pressure Bloating Gas

actual size

30 Caplets*

*Capsule-Shaped Tablets

INGREDIENTS AND APPEARANCE

ANTI DIARRHEAL ANTI GAS
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)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 46122-566-65	1 in 1 CARTON	12/28/2018
1		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209837	12/28/2018

Labeler - Amerisource Bergen (007914906)

Anti Diarrheal Anti Gas by