OTC Medication Information: Anti Diarrheal and Anti Gas

ANTI DIARRHEAL AND ANTI GAS- loperamide hydrochloride and dimethicone tablet
CVS Pharmacy

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 20° -25° C (68° -77° F). 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

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredients in Imodium® Multi-Symptom Relief

Anti-Diarrheal & Anti-Gas

LOPERAMIDE HYDROCHLORIDE & SIMETHICONE TABLETS, 2 mg/125 mg

ANTI-DIARRHEAL/ANTI-GAS

Multi-symptom relief caplet

Relieves symptoms of diarrhea plus:

Cramps & pressure

Bloating

Gas

24 CAPLETS*

*Capsule-shaped tablets

Actual Size

anti diarrheal and anti gas image
(click image for full-size original)
ANTI DIARRHEAL AND ANTI GAS
loperamide hydrochloride, simethicone tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-644
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg
DIMETHICONE (DIMETHICONE) DIMETHICONE 125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
ACESULFAME POTASSIUM
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
PROPYLENE GLYCOL
STEARIC ACID
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 17mm
Flavor Imprint Code L0R1;2;125
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-644-62 24 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (69842-644-62)
2 NDC:69842-644-53 12 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (69842-644-53)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209837 08/06/2019
Labeler — CVS Pharmacy (062312574)

Revised: 10/2022 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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