ANTI-DIARRHEAL- loperamide hcl tablet

Anti-Diarrheal by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient(in each caplet)

Loperamide HCI 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 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
• 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

• 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 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 2-5 years (34-47 lbs): ask a doctor
• children under 2 years(up to 33 lbs): do not use

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 lake, dibasic calcium phosphate
dihydrate, FD&C blue #1 lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

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: 80136-381
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
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	OVAL	Size	10mm
Flavor		Imprint Code	44;375
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80136-381-24	4 in 1 CARTON	09/01/2020
1		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
ANDA	ANDA076497	09/01/2020

Labeler - Northeast Pharma (081232935)

Registrant - Geri-Care Pharmaceutical Corp (611196254)