LOPERAMIDE HCL- loperamide hcl tablet
L.N.K. International, Inc.

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LNK 44-375

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.

Heart alert: Taking more than directed can cause serious heart problems or death.

Do not use

if you have bloody or black stool.

Ask a doctor before use if you have

a 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 (1-800-222-1222) right away.

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

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store between 20°-25°C (68°-77°F)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

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Equaline

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Exchange Select

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Family Wellness

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HealthCare

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HEB

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Magno Humphries

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Members Mark

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Premier Value

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Quality Choice 44-375

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Quality Plus

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Quality Plus

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Rite Aid 44-375

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Signature Care

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Sound Body

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Walgreens

LOPERAMIDE HCL
loperamide hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50844-847
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
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)

Product Characteristics
Color	GREEN	Score	2 pieces
Shape	OVAL	Size	10mm
Flavor		Imprint Code	44;375
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50844-847-26	1 in 1 BOX	05/03/2005
1		107000 in 1 BAG; Type 0: Not a Combination Product
2	NDC:50844-847-44	3 in 1 CARTON	05/03/2005
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:50844-847-01	5 in 1 CARTON	05/03/2005
3		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:50844-847-07	6 in 1 CARTON	05/03/2005
4		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:50844-847-08	4 in 1 CARTON	05/03/2005
5		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC:50844-847-87	3 in 1 CARTON	05/03/2005
6		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC:50844-847-45	1 in 1 CARTON	05/03/2005
7		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
8	NDC:50844-847-88	8 in 1 CARTON	05/03/2005
8		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
9	NDC:50844-847-02	2 in 1 CARTON	05/03/2005
9		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
10	NDC:50844-847-06	1 in 1 CARTON	05/03/2005
10		200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
11	NDC:50844-847-96	2 in 1 CARTON	05/03/2005
11		200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
12	NDC:50844-847-22	1 in 1 CARTON	05/03/2005
12		48 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
13	NDC:50844-847-23	1 in 1 CARTON	05/03/2005
13		72 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
14	NDC:50844-847-46	1 in 1 CARTON	05/03/2005
14		96 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT	ANDA076497	05/03/2005

Labeler - L.N.K. International, Inc. (038154464)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(50844-847)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(50844-847)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(50844-847)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(50844-847)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(50844-847)

Revised: 2/2018

Document Id: 2d364740-1278-4c0e-b085-e36e62f35dae

Set id: 9e97d5d7-373e-41d7-afa1-7c57cf2e7b1a

Version: 4

Effective Time: 20180222

L.N.K. International, Inc.