SIMETHICONE tablet, chewable

SIMETHICONE by

Drug Labeling and Warnings

SIMETHICONE by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP., UNITDOSE SERVICES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Simethicone 80 mg

Purpose

Anti-Gas

Uses

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

Warnings

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.

Directions

• chew or crush tablet completely before swallowing
• adults and children 12 years and over: take 1-2 tablets as needed after meals and at bedtime.

Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor.

• children under 12 years: ask a doctor

Other information

• each tablet contains: calcium 65 mg
• Tamper Evident: Do not use if imprinted seal under cap is missing or broken
• store at room temperature, 15°C - 30°C (59˚F - 86˚F)
• protect from moisture

Inactive ingredients

cellulose, corn starch, crospovidone, dextrates hydrated, flavor,
magnesium stearate, silica, sucralose, calcium phosphate.

Questions or comments?

DISTRIBUTED BY: 

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

package Label

INGREDIENTS AND APPEARANCE

SIMETHICONE 
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-0791(NDC:57896-791)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
DEXTRATES (UNII: G263MI44RU)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	13mm
Flavor	PEPPERMINT	Imprint Code	44;137
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-0791-1	50 in 1 BOX	04/11/2022
1	NDC: 17856-0791-2	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	02/10/2022

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
UNIT DOSE SOLUTIONS		360804194	repack(17856-0791)