Search by Drug Name or NDC

NDC 00113-1087-89 Good Sense Anti Diarrheal Anti Gas 125; 2 mg/1; mg/1 Details

Good Sense Anti Diarrheal Anti Gas 125; 2 mg/1; mg/1

Good Sense Anti Diarrheal Anti Gas is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by L. Perrigo Company. The primary component is DIMETHICONE; LOPERAMIDE HYDROCHLORIDE.

MedlinePlus Drug Summary

Nonprescription (over-the-counter) loperamide is used to control acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travelers' diarrhea. Prescription loperamide is also used to control acute diarrhea and also ongoing diarrhea associated with inflammatory bowel disease (IBD; condition in which the lining of all or part of the intestine is swollen, irritated, or has sores). Prescription loperamide is also used to reduce the amount of fluid in people with ileostomies (surgery to create an opening for waste to leave the body through the abdomen). Loperamide is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel and by slowing down the movement of the bowel to decrease the number of bowel movements.

Related Packages: 00113-1087-89
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loperamide

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 00113-1087-89
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	00113-1087
Product ID	0113-1087_fcfd0b64-6876-4e6f-8a7b-ca1da9e03f00
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Good Sense Anti Diarrheal Anti Gas
Proprietary Name Suffix	n/a
Non-Proprietary Name	loperamide hydrochloride, simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	125; 2
Active Ingredient Units	mg/1; mg/1
Substance Name	DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
Labeler Name	L. Perrigo Company
Pharmaceutical Class	Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA209837
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00113-1087-89 (00113108789)

Pricing Information	N/A
NDC Package Code	0113-1087-89
Billing NDC	00113108789
Package	18 BLISTER PACK in 1 CARTON (0113-1087-89) / 1 TABLET in 1 BLISTER PACK
Marketing Start Date	2019-01-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fcfd0b64-6876-4e6f-8a7b-ca1da9e03f00 Details

Active ingredients (in each caplet)

Loperamide HCl 2 mg

Simethicone 125 mg

Purposes

Anti-diarrheal

Anti-gas

Uses

relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

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
•: if you have difficulty swallowing

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.
•: you have difficulty swallowing the caplet

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
•: take only on an empty stomach (1 hour before or 2 hours after a meal)
•: take with a full (8 oz.) glass of water
•: find right dose on chart below. 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; ½ 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; ½ 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

•: each caplet contains: calcium 165 mg, sodium 3 mg
•: store between 20°-25°C (68°-77°F). Protect from light.
•: do not use if printed blister unit is broken or torn

Inactive ingredients

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, maltodextrin, microcrystalline cellulose, natural and artificial flavor, propylene glycol, stearic acid

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Multi-Symptom Relief Caplet

See New Warning and Directions

Loperamide Hydrochloride and Simethicone Tablets, 2mg/125mg

Anti-Diarrheal/Anti-Gas

Actual Size

Relieves symptoms of diarrhea plus

Cramps & Pressure – Bloating – Gas

Compare to active ingredients of Imodium® Multi-Symptom Relief

100% SATISFACTION GUARANTEED

18 Caplets*

*Capsule-Shaped Tablets

INGREDIENTS AND APPEARANCE

GOOD SENSE ANTI DIARRHEAL ANTI GAS

loperamide hydrochloride, simethicone tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0113-1087
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	L0R1;2;125
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0113-1087-89	18 in 1 CARTON	01/29/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209837	01/29/2019

Labeler - L. Perrigo Company (006013346)

Revised: 2/2019

Document Id: fcfd0b64-6876-4e6f-8a7b-ca1da9e03f00

Set id: fcfd0b64-6876-4e6f-8a7b-ca1da9e03f00

Version: 1

Effective Time: 20190226