CARE ONE ANTI DIARRHEAL LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride tablet, film coated
American Sales Company

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American Sales Company Anti-Diarrheal Drug Facts

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Do not use

if you have bloody or black stool

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.

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
•: find right dose on chart. 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; 1/2 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; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs)	ask a doctor

Other information

•: store at 20°-25°C (68°-77°F)
•: do not use if printed foil under cap is broken or missing
•: see end panel for lot number and expiration date

Inactive ingredients

anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to active ingredient in Imodium® A-D

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal

Controls The Symptoms Of Diarrhea

Actual Size

Easy To Swallow, Small Caplets

*Each Caplet (Capsule-Shaped Tablet) Contains 2 mg Loperamide Hydrochloride

Anti-Diarrheal Carton Image 1

Anti-Diarrheal Carton Image 2

CARE ONE ANTI DIARRHEAL LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-224
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	GREEN	Score	2 pieces
Shape	OVAL	Size	10mm
Flavor		Imprint Code	L2
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-224-53	2 in 1 CARTON	01/23/2004	07/16/2018
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:41520-224-62	4 in 1 CARTON	01/23/2004	07/16/2018
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:41520-224-67	1 in 1 CARTON	01/23/2004	07/16/2018
3		48 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	ANDA075232	01/23/2004	07/16/2018

Labeler - American Sales Company (809183973)

Revised: 10/2018

Document Id: ae5002e7-c96e-47cb-a191-f7ed61b59412

Set id: 639f7cc2-9fe4-43c3-a2bb-04bb528d74af

Version: 2

Effective Time: 20181019

American Sales Company