SIMETHICONE 80 MG- simethicone tablet, chewable

Simethicone 80 mg by

Drug Labeling and Warnings

Simethicone 80 mg by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Use

relieves bloating, pressure and fullness commonly referred to as gas

Warnings

Keep out of reach of children

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 then 6 tablets per day

Other information

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

Inactive ingredients

compressible sugar, dextrose, maltodextrin, micdocrystalline cellulose, peppermint flavor, Silicon dioxide, sorbitol, stearic acid

Questions or comments?

call 516-341-0666, 8:30 am to 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

Distributed by: Reliable 1 Laboratories LLC

Valley Stream, NY 11580

Repackaged by: Proficient Rx LP

Thousand Oaks, CA 91320

www.reliable1labs.com

Active ingredient (in each chewable tablet)

Simethicone 80 mg

Purpose

Antiflatulent

PRINCIPAL DISPLAY PANEL

NDC: 82804-043-30

Simethicone 80 mg

ANTIFLATULENT

30 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

SIMETHICONE 80 MG 
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82804-043(NDC:69618-033)
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
PEPPERMINT (UNII: V95R5KMY2B)

Product Characteristics
Color	white (Off White)	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	AP;019
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82804-043-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2023
2	NDC: 82804-043-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2023
3	NDC: 82804-043-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/16/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	04/24/2018

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(82804-043) , RELABEL(82804-043)