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NDC 63187-0516-00 PlusPHARMA 80 mg/1 Details

PlusPHARMA 80 mg/1

PlusPHARMA is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is DIMETHICONE.

MedlinePlus Drug Summary

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 63187-0516-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	63187-0516
Product ID	63187-516_cf994666-c728-4a3b-a73e-f3709cbb141b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	PlusPHARMA
Proprietary Name Suffix	n/a
Non-Proprietary Name	Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	80
Active Ingredient Units	mg/1
Substance Name	DIMETHICONE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0516-00 (63187051600)

Pricing Information	N/A
NDC Package Code	63187-516-00
Billing NDC	63187051600
Package	100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (63187-516-00)
Marketing Start Date	2018-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4242fb32-a04f-4f46-99e2-ca01fcb2ee9f Details

Active ingredient (in each tablet)

Simethicone 80 mg, USP

Purpose

Anti-Gas

Uses

Relieves bloating and pressure commonly referred to as gas.

Warnings

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

Keep this and all drugs out of the reach of children.

Directions

•: Adults: Chew 1 or 2 tablets as needed after meals and at bedtime.
•: Do not exceed 6 tablets per day except under the advice and supervision of a physician.

Other Information

•: Store at room temperature.
•: Avoid high humidity.
•: Do not use if imprinted safety seal under cap is broken or missing.

Inactive ingredients

Fructose, Maltodextrin, Natural and Artificial Spearmint Flavor, Silicon Dioxide, Sorbitol, Starch and Stearic Acid.

Questions?

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

Principal Display Panel

PlusPHARMA

SIMETHICONE 80 mg

ANTI GAS

Acts Fast to Relieve:

•: Bloating
•: Discomfort
•: Pressure

Compare to the Active Ingredient in Gas-X® Chewables.

This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Gas-X® Chewables.

100 CHEWABLE TABLETS 80mg Each

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

PLUSPHARMA

simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-516(NDC:51645-860)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
FRUCTOSE (UNII: 6YSS42VSEV)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (Round Flat Faced Beveled Edge)	Size	13mm
Flavor	SPEARMINT (Natural and Artificial)	Imprint Code	GPI;LB
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63187-516-00	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/27/2006

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-516) , RELABEL(63187-516)

Revised: 1/2021

Document Id: cf994666-c728-4a3b-a73e-f3709cbb141b

Set id: 4242fb32-a04f-4f46-99e2-ca01fcb2ee9f

Version: 3

Effective Time: 20210101