Drug Facts

Active ingredient

(in each sugar-coated tablet)

Simethicone 60 mg

Purpose

Anti-gas

Use

Relief of bloating and pressure commonly referred to as gas.

Warnings

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

Keep out of reach of children.

Directions

Adults and children over 12 years: one or two tablets daily, taken with meal or at bedtime.

Do not exceed 8 tablets per day except under the advice and supervision of a physician.

Other information

Store below 25°C (77°F).

Inactive ingredients

Calcium Phosphate Dibasic, Carnauba Wax, Corn Starch, FD&C Red No. 3 (Erythrosine), Gelatin, Corn Starch (Pregelatinized), Lactose Monohydrate, Hypromellose Phthalate (31% phthalate, 40 CST), Polyoxyl 40 Stearate, Polysorbate 80, Povidone K-30, Sucrose granules, Sodium Starch Glycolate, Talc, Titanium

Questions or comments?

https://www.synmosa.com.tw/en/Inquiry/ugC_Inquiry.asp

TAMPER EVIDENT

Do not use if blister unit is torn, broken or shows any signs of tampering.

Simethicone Enteric S.C.

Tablets 60 mg

Composition:

Each S.C. tablet contains:

Simethicone . . . . . 60 mg

Anti Gas

Acts Fast to Relieve

Gas Pressure
Bloating
Gas Discomfort

Manufactured by:

Synmosa Biopharma Corporation,Synmosa Plant

No. 6, Kuang Yeh 1 st Road, Hu-Kuo Hsiang

Hsin-Chu Ind. Park, Hsin Chu Hsien

Taiwan, R.O.C.

Made in Taiwan (R.O.C.)

synmosa

ANTI-GAS

Simethicone Enteric S.C. Tablets 60 mg

Keep outer carton for complete warnings and product information

OTC Anti-Gas Ingredient

100 Tablets

label

SIMETHICONE ENTERIC S.C.
simethicone tablet, sugar coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83931-001
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	60 mg

Ingredient Name	Strength
Inactive Ingredients
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SUCROSE (UNII: C151H8M554)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POVIDONE K30 (UNII: U725QWY32X)
TITANIUM (UNII: D1JT611TNE)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
CARNAUBA WAX (UNII: R12CBM0EIZ)
GELATIN (UNII: 2G86QN327L)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83931-001-01	10 in 1 BOX	04/01/2024
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M002	04/01/2024

Labeler - Synmosa Biopharma Corporation Synmosa Plant (657895530)

Name	Address	ID/FEI	Business Operations
Establishment
Synmosa Biopharma Corporation Synmosa Plant		657895530	manufacture(83931-001)

Simethicone Anti-Gas