FAD FIRST AID DIRECT ANTI-DIARRHEAL- loperamide hcl tablet, film coated

fad first aid direct anti-diarrheal by

Drug Labeling and Warnings

fad first aid direct anti-diarrheal by is a Otc medication manufactured, distributed, or labeled by First Aid Direct. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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 2-5 years (34 to 47 lbs):

  ask a doctor

• children under 2 years (up to 33 lbs):

  do not use

Other information

• store at 20°-25°C (68°-77°F)
• 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

See New Warning and Directions

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal

Controls the Symptoms of Diarrhea

Compare to active ingredient of Imodium® A-D

DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN

Actual Size

Anti-Diarrheal

12 CAPLETS**

** Capsule-Shaped Tablets

INGREDIENTS AND APPEARANCE

FAD FIRST AID DIRECT ANTI-DIARRHEAL 
loperamide hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53117-224
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 LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53117-224-53	12 in 1 CARTON	10/15/2014
1		1 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	ANDA075232	10/15/2014

Labeler - First Aid Direct (962283128)