LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE - loperamide hydrochloride and simethicone tablet 
Better Living Brands, LLC

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Drug Facts

Active ingredients (in each caplet) 

Loperamide HCl USP 2 mg
Simethicone USP 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


Ask a doctor before use if you have

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

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

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 to 11 years (60 to 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 to 8 years (48 to 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 to 5 years (34 to 47 lbs)
ask a doctor
children under 2 years (up to 33 lbs)
do not use

Other information

Inactive ingredients

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate anhydrous, flavor, microcrystalline cellulose, stearic acid.

Questions or comments?

call 1-855-274-4122

(Monday – Friday 8:30 AM to 5:00 PM EST)


DISTRIBUTED BY:
BETTER LIVING BRANDS LLC
P.O.BOX 99
PLEASANTON, CA 94566-0009
‡1-888-723-3929

Made in India
Code: AP/DRUGS/04/2016


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (24 Caplets) Blister Carton Label

Compare to
Imodium®
Multi-Symptom Relief
active ingredients**
NDC 21130-222-24
MULTI-SYMPTOM RELIEF CAPLET
Anti - Diarrheal/ Anti - Gas
LOPERAMIDE HCl AND SIMETHICONE TABLETS
2 mg/125 mg

Anti-Diarrheal/ Anti-Gas
Relieves symptoms of diarrhea plus
        •   
Cramps & Pressure
        •    Bloating
        •    Gas

Actual Size
24 CAPLETS*
*capsule-shaped tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (24 Caplets) Blister Carton Label

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 
loperamide hydrochloride and simethicone tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-222
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITE (off-white) Score2 pieces
ShapeCAPSULESize17mm
FlavorVANILLAImprint Code T;79
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-222-763 in 1 CARTON07/21/2023
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:21130-222-244 in 1 CARTON07/21/2023
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21105907/21/2023
Labeler - Better Living Brands, LLC (009137209)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(21130-222) , MANUFACTURE(21130-222)

Revised: 7/2023
Document Id: 8cc74573-9503-42e7-8ee8-c574c6acc900
Set id: fad9a144-6d1e-be06-e053-6394a90a870c
Version: 2
Effective Time: 20230721
 
Better Living Brands, LLC