LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE - loperamide hydrochloride and simethicone tablet 
Camber Consumer Care Inc

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Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC)

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

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


6scarton

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE  
loperamide hydrochloride and simethicone tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-325
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeCAPSULESize17mm
FlavorVANILLAImprint Code H;L21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69230-325-041 in 1 CARTON06/17/2021
1NDC:69230-325-314 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:69230-325-082 in 1 CARTON06/17/2021
2NDC:69230-325-314 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:69230-325-061 in 1 CARTON06/17/2021
3NDC:69230-325-326 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:69230-325-122 in 1 CARTON06/17/2021
4NDC:69230-325-326 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:69230-325-183 in 1 CARTON06/17/2021
5NDC:69230-325-326 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:69230-325-244 in 1 CARTON06/17/2021
6NDC:69230-325-326 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21143806/17/2021
Labeler - Camber Consumer Care Inc (079539968)
Establishment
NameAddressID/FEIBusiness Operations
Annora Pharma Private Limited650980746analysis(69230-325) , manufacture(69230-325)

Revised: 6/2021
Document Id: c54647cd-91fb-3734-e053-2995a90a29bf
Set id: e2a4af66-1d05-408c-9f11-f2a9f325d75c
Version: 2
Effective Time: 20210621
 
Camber Consumer Care Inc