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

Drug Labeling and Warnings

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

• Sodium free
• 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:

anhydrous citric acid, carnauba wax, corn syrup solids, croscarmellose sodium, crospovidone, glycerin, maltitol syrup, mannitol, microcrystalline cellulose, starch, sucralose, trisodium calcium phosphate.

Questions or comments?

Call 1-800-227-6151

SPL UNCLASSIFIED SECTION

Patents: www.uspharmaltd.com/patent

Principal display Panel-250 mg bottle label

FIRSTCARE

Compare to the active

ingredient in Gas-X®

NDC: 71594-711-15

Gas Relief

SIMETHICONE 250 mg

Anti-gas

Fast Relief of:

Bloating, Pressure,
Gas discomfort

Dye-Free

Cherry Creme

48 Soft Chewables

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71594-711
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CORN SYRUP (UNII: 9G5L16BK6N)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Product Characteristics
Color	white (Off-white)	Score	2 pieces
Shape	ROUND	Size	14mm
Flavor	CHERRY (Cherry Creme)	Imprint Code	7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71594-711-15	48 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	05/12/2026

Labeler - USpharma Ltd (080664601)

Registrant - USpharma Ltd (080664601)

Establishment
Name	Address	ID/FEI	Business Operations
USpharma Ltd		080664601	manufacture(71594-711) , pack(71594-711)