ANTIDIARRHEAL RELIEF- loperamide hcl tablet

Antidiarrheal Relief by

Drug Labeling and Warnings

Antidiarrheal Relief by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc, OHM LABORATORIES INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Loperamide HCl USP 2 mg

Purpose

Antidiarrheal

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 attack: 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 doctorif

• diarrhea lasts for more than 2 days
• symptoms get worse
• you get abdominal swelling or bulging.

These may be signsor 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.

SPL UNCLASSIFIED SECTION

Do not use if individual packet is torn or open.

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 (60-95Ibs) 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(48-59lbs) 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

Inactive ingredients

anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Questions?

call 1-800-430-5490

PRINCIPAL DISPLAY PANEL

MM1

Antidiarrheal Label

INGREDIENTS AND APPEARANCE

ANTIDIARRHEAL RELIEF 
loperamide hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-1071
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
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 68401960MK)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
CORN OIL (UNII: 8470G57WFM)

Product Characteristics
Color	green (Bright Green)	Score	2 pieces
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	123
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-1071-07	100 in 1 CARTON	11/07/2018
1	NDC: 0498-1071-00	1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074091	04/29/2013

Labeler - Honeywell Safety Products USA, Inc (079287321)

Registrant - Honeywell Safety Products USA, Inc (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	repack(0498-1071)

Establishment
Name	Address	ID/FEI	Business Operations
OHM LABORATORIES INC.		184769029	manufacture(0498-1071)