FIRSTCARE MAXIMUM STRENGTH GAS RELIEF SIMETHICONE 250 MG ANTI-GAS- simethicone tablet, chewable 
USpharma Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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FIRSTCARE MAXIUMUM STRENGTH GAS RELIEF SIMETHICONE 250 mg Anti-gas



DRUG FACTS

Active ingredient (in each chewable)

Simethicone, 250 mg

Purpose

Antigas

Uses

for the relief of

Keep out of reach of children.

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Directions

Other information

Inactive ingredients:

carnauba wax, citric acid, croscarmellose sodium, crospovidone, FD&C red #40, flavors, glucose syrup, glycerin, gum arabic, maltitol solution,mannitol, powdered milk, propylene glycol, sorbitol, starch, sucralose, sucrose.

Questions or comments?

Call 1-800-227-6151

USpharma

13900 NW 57th Court, Miami Lakes, FL 33014

1-800-227-6151 www.uspharmaltd.com

Principal display Panel-250 mg bottle label

FIRSTCARE

MADE IN USA

NDC 71594-707-08

MAXIMUM STRENGTH

GAS RELIEF

SIMETHICONE 250 mg

Anti-gas

Fast Relief of:

Bloating, Pressure,
Gas discomfort

Mixed Berry Flavor

20 SOFT CHEWABLES

Principal display Panel-250 mg bottle label

FIRSTCARE MAXIMUM STRENGTH GAS RELIEF SIMETHICONE 250 MG ANTI-GAS 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71594-707
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 2S7830E561)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CORN SYRUP (UNII: 9G5L16BK6N)  
GLYCERIN (UNII: PDC6A3C0OX)  
ACACIA (UNII: 5C5403N26O)  
MALTITOL (UNII: D65DG142WK)  
MANNITOL (UNII: 3OWL53L36A)  
MILK PROTEIN CONCENTRATE (UNII: 871QYF3I7B)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorredScoreno score
ShapeSQUARESize15mm
FlavorBERRY (MIXED BERRY) Imprint Code 7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71594-707-0820 in 1 BOTTLE; Type 0: Not a Combination Product07/04/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33207/04/2023
Labeler - USpharma Ltd (080664601)
Establishment
NameAddressID/FEIBusiness Operations
USpharma Ltd080664601manufacture(71594-707)

Revised: 5/2023
Document Id: faf85f55-9828-79d0-e053-6394a90abc6c
Set id: fa8cf730-19b3-4354-bc50-68a6f877c981
Version: 1
Effective Time: 20230505
 
USpharma Ltd