LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE- loperamide hydrochloride and simethicone tablet

Loperamide Hydrochloride and Simethicone by

Drug Labeling and Warnings

Loperamide Hydrochloride and Simethicone by is a Otc medication manufactured, distributed, or labeled by Camber Consumer Care Inc, Annora Pharma Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PREGNANCY OR BREAST FEEDING

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211438	06/17/2021

Labeler - Camber Consumer Care Inc (079539968)

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