IMODIUM MULTI-SYMPTOM RELIEF- loperamide hydrochloride and dimethicone tablet

IMODIUM by

Drug Labeling and Warnings

IMODIUM by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)	Purposes
Loperamide HCl 2 mg	Anti-diarrheal
Simethicone 125 mg	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 blister unit is torn or broken

Inactive ingredients

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

Questions or comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

See New Warning and Directions

NDC: 50580-338-61

Imodium®
Loperamide HCl, 2 mg/Simethicone, 125 mg Antidiarrheal/Anti-gas

Multi-Symptom Relief
Caplet

Relieves symptoms
of diarrhea plus

• Cramps & Pressure
• Bloating
• Gas

24 Caplets*

*capsule-shaped tablets
Actual Size

INGREDIENTS AND APPEARANCE

IMODIUM   MULTI-SYMPTOM RELIEF
loperamide hydrochloride and dimethicone tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-338
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Loperamide Hydrochloride (UNII: 77TI35393C) (Loperamide - UNII:6X9OC3H4II)	Loperamide Hydrochloride	2 mg
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	125 mg

Inactive Ingredients
Ingredient Name	Strength
acesulfame potassium (UNII: 23OV73Q5G9)
croscarmellose sodium (UNII: M28OL1HH48)
dibasic calcium phosphate dihydrate (UNII: O7TSZ97GEP)
microcrystalline cellulose (UNII: OP1R32D61U)
stearic acid (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	OVAL	Size	16mm
Flavor		Imprint Code	IMO;2;125
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-338-12	2 in 1 CARTON	07/01/2008
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50580-338-18	3 in 1 CARTON	07/01/2008
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 50580-338-42	1 in 1 CARTON	07/01/2008
3		42 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 50580-338-30	1 in 1 CARTON	07/01/2008
4		30 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 50580-338-60	2 in 1 PACKAGE	06/14/2013
5	NDC: 50580-338-30	1 in 1 CARTON
5		30 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 50580-338-61	4 in 1 CARTON	06/24/2019
6		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021140	07/01/2008

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)