SIMETHICONE 125 MG- simethicone tablet, chewable

Simethicone 125 mg by

Drug Labeling and Warnings

Simethicone 125 mg by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP., UNIT DOSE SOLUTIONS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable tablet)

Simethicone 125 mg

PURPOSE

Antiflatulent

Use

relieves bloating, pressure and fullness commonly referred to as gas

Warnings

Keep out of reach of children

TAMPER EVIDENT: DO NOT USE IF SAFETY POUCH LOOKS TO BE TEMPERED OR OPEN

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Directions

• thoroughly chew 1-2 tablets as needed after meals and at bedtime
• do not take more than 4 tablets per day

Other information

store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

compressible sugar, dextrose, maltodextrin, microcrystaline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid

How Supplied

NDC: 17856-0137-01

Box of 100 Chewable Tablets.................................. 17856-0137-01

ANTIFLATULENT

Questions or comments?

Distributed by:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Call 1-800-509-7592

M-F 8 am - 5 pm EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIMETHICONE 125 MG 
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-0137(NDC:69618-032)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PEPPERMINT (UNII: V95R5KMY2B)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
DEXTROSE (UNII: IY9XDZ35W2)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white (Off white)	Score	2 pieces
Shape	ROUND	Size	16mm
Flavor		Imprint Code	AP;040
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-0137-1	100 in 1 BOX, UNIT-DOSE	09/29/2022
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 17856-0137-2	1 in 1 POUCH; Type 0: Not a Combination Product	09/29/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	04/25/2018

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
UNIT DOSE SOLUTIONS		360804194	repack(17856-0137)