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NDC 69230-0325-04 Loperamide Hydrochloride and Simethicone 125; 2 mg/1; mg/1 Details

Loperamide Hydrochloride and Simethicone 125; 2 mg/1; mg/1

Loperamide Hydrochloride and Simethicone is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Camber Consumer Care Inc. 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: 69230-0325-04
Last Updated: 12/01/2022
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: 69230-0325-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	69230-0325
Product ID	69230-325_e875c38b-493f-1f9f-e053-2995a90a6cd1
Associated GPIs	47991002080320
GCN Sequence Number	048990
GCN Sequence Number Description	loperamide HCl/simethicone TABLET 2-125MG ORAL
HIC3	D6D
HIC3 Description	ANTIDIARRHEALS
GCN	14984
HICL Sequence Number	015777
HICL Sequence Number Description	LOPERAMIDE HCL/SIMETHICONE
Brand/Generic	Generic
Proprietary Name	Loperamide Hydrochloride and Simethicone
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loperamide Hydrochloride and 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	Camber Consumer Care Inc
Pharmaceutical Class	Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA211438
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69230-0325-04 (69230032504)

Pricing Information	N/A
NDC Package Code	69230-325-04
Billing NDC	69230032504
Package	1 BLISTER PACK in 1 CARTON (69230-325-04) / 4 TABLET in 1 BLISTER PACK
Marketing Start Date	2021-06-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e2a4af66-1d05-408c-9f11-f2a9f325d75c Details

ACTIVE INGREDIENT(S)

(in each tablet)

Loperamide Hydrochloride USP 2 mg

Simethicone USP 125 mg

PURPOSES

Anti-diarrheal

Anti-gas

USE(S)

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 hydrochloride

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

• 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

• 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 tablet

SPL UNCLASSIFIED SECTION

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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours
children 9-11 years (60-95 lbs)	1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours
children 6-8 years (48-59 lbs)	1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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 tablet contains: calcium 640 mg, very low sodium and potassium 5.838 mg

• store between 20 to 25°C (68 to 77°F). Protect from light.

• do not use if carton is open or if blister unit is open or torn

INACTIVE INGREDIENTS

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor

QUESTIONS OR COMMENTS

call 1-888-588-1418

Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA.

PRINCIPAL DISPLAY PANEL

Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-1x6's carton

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

loperamide hydrochloride and simethicone tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69230-325
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	CAPSULE	Size	17mm
Flavor	VANILLA	Imprint Code	H;L21
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69230-325-04	1 in 1 CARTON	06/17/2021
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:69230-325-08	2 in 1 CARTON	06/17/2021
2		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:69230-325-06	1 in 1 CARTON	06/17/2021
3		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:69230-325-12	2 in 1 CARTON	06/17/2021
4		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:69230-325-18	3 in 1 CARTON	06/17/2021
5		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC:69230-325-24	4 in 1 CARTON	06/17/2021
6		6 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	ANDA211438	06/17/2021

Labeler - Camber Consumer Care Inc (079539968)

Name	Address	ID/FEI	Business Operations
Establishment
Annora Pharma Private Limited		650980746	manufacture(69230-325)

Revised: 9/2022

Document Id: e875c38b-493f-1f9f-e053-2995a90a6cd1

Set id: e2a4af66-1d05-408c-9f11-f2a9f325d75c

Version: 3

Effective Time: 20220912