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

Firstcare Maximum Strength Gas Relief Simethicone 250 mg Anti-gas by

Drug Labeling and Warnings

Firstcare Maximum Strength Gas Relief Simethicone 250 mg Anti-gas by is a Otc medication manufactured, distributed, or labeled by USpharma Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each chewable)

Simethicone, 250 mg

Purpose

Antigas

Uses

for the relief of

• pressure, bloating, and fullness commonly referred to as gas

WARNINGS

Keep out of reach of children.

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

Directions

• adults and children 12 years and older: take 1 or 2 chewables as needed after meals and at bedtime.
• do not exceed 2 chewables in 24 hours except under the advice and supervision of a physician.

Other information

• each chewable contains  sodium 5 mg. very low sodium
• store at controlled room temperature 20-25°C (68-77°F).
• protect from light, heat and moisture.
• Child Resistant Container; do not use if printed seal under cap is broken or missing.

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71594-707
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	250 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score	no score
Shape	SQUARE	Size	15mm
Flavor	BERRY (MIXED BERRY)	Imprint Code	7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71594-707-08	20 in 1 BOTTLE; Type 0: Not a Combination Product	07/04/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	07/04/2023

Labeler - USpharma Ltd (080664601)

Establishment
Name	Address	ID/FEI	Business Operations
USpharma Ltd		080664601	manufacture(71594-707)