ANTI-DIARRHEAL- loperamide hcl tablet

Anti-Diarrheal by

Drug Labeling and Warnings

Anti-Diarrheal by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals 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

Do not use

• if you have bloody or black stool

Ask a doctor before use if you have

• 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
• 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,which may accompany diarrhea

• do not exceed recommended dose
• Adults and children 12 years and over: 2 caplets after the first loose bowel movement; 1 caplet after each subsequent loose bowel movement; do not exceed 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, dicalcium phosphate, FD C Blue #1, magnesium stearate, silica gel

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

package Label

NDC: 68788-7369-2

GERICARE

Anti-Diarrheal

Loperamide HCl

Controls the symptoms of diarrhea

*compare to the active ingredient in imodium A-D

24 caplets

2 mg each

Tamper Evident: Do not use if imprinted seal under cap is broken or missing

Relabeled By: Preferred Pharmaceuticals Inc.

INGREDIENTS AND APPEARANCE

ANTI-DIARRHEAL 
loperamide hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-7369(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)
MICROCRYSTALLINE CELLULOSE (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: 68788-7369-2	24 in 1 BOTTLE; Type 0: Not a Combination Product	08/25/2016
2	NDC: 68788-7369-1	12 in 1 BOTTLE; Type 0: Not a Combination Product	06/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076497	08/25/2016

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-7369)