ANTI-DIARRHEAL- loperamide hcl tablet

Anti-Diarrheal by

Drug Labeling and Warnings

Anti-Diarrheal by is a Otc medication manufactured, distributed, or labeled by Geri-Care Pharmaceutical Corp, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(in each caplet)

Loperamide HCI 2 mg

Purpose

Anti-diarrheal

Uses

• 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 HCI

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 present in your 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

• diarrhea lasts for more than 2 days
• symptoms get worse
• 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

• 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 under 12 years: ask a doctor

Other Information

• TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
• store at 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive Ingredients

cellulose, corn starch, D&C Yellow #10 lake, dicalcium phosphate, FD&C Blue #1 lake, magnesium stearate, silica

Questions or comments? call 1-800-540-3765

package Label

INGREDIENTS AND APPEARANCE

ANTI-DIARRHEAL 
loperamide hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-381
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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	green (light green)	Score	2 pieces
Shape	CAPSULE	Size	7mm
Flavor		Imprint Code	44375
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-381-12	12 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2006
2	NDC: 57896-381-24	24 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2006
3	NDC: 57896-381-48	48 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2006
4	NDC: 57896-381-96	96 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076497	01/01/2006

Labeler - Geri-Care Pharmaceutical Corp (611196254)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	manufacture(57896-381)