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FDA LABEL GENERIC: Loperamide MFR: FSA store INC

Loperamide Hcl 2 Mg / Simethicone 125 Mg Oral Tablet

Table of Contents

ACTIVE INGREDIENT(S)

(in each tablet)
Loperamide Hydrochloride USP 2 mg
Simethicone USP 125 mg

PURPOSES

Anti-diarrheal
Anti-gas

USE(S)

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 hydrochloride
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 aretaking 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 tablet

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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours

children 9-11 years
(60-95 lbs) 		1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours

children 6-8 years

(48-59 lbs)
1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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 tablet contains: calcium 640 mg, very low sodium and potassium 5.838 mg
• store between 20 to 25°C (68 to 77°F). Protect from light.
• do not use if carton is open or if blister unit is open or torn

INACTIVE INGREDIENTS

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor

QUESTIONS OR COMMENTS

call 1-888-588-1418


Manufactured for FSA Store Inc. 
473 Blair Rd Suite 100 
PMB 24308 Dallas, TX 75231 
Customer Help Line: 1-888-588-1418

PRINCIPAL DISPLAY PANEL

Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-1x6's carton


Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-6's foil