FDA.reportPublic FDA data

PlusPHARMA

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2021-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:57:10

Label at a glance#

ProductPlusPHARMA
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

Relieves bloating and pressure commonly referred to as gas.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 80 mg, USP


Purpose

OTC - PURPOSE SECTION

Anti-Gas


Uses

INDICATIONS & USAGE SECTION

Relieves bloating and pressure commonly referred to as gas.


Warnings

WARNINGS SECTION


OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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


Questions?

OTC - QUESTIONS SECTION

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


Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66267-643-022024-08-15C16284748780-1f386c649-e311-0266-e053-dadaa90a7c1aDrug Facts
66267-643-302024-08-15C16284748780-1f386c649-e311-0266-e053-dadaa90a7c1aDrug Facts
66267-643-602024-08-15C16284748780-1f386c649-e311-0266-e053-dadaa90a7c1aDrug Facts
66267-643-982024-08-15C16284748780-1f386c649-e311-0266-e053-dadaa90a7c1aDrug Facts
66267-643-022023-01-30C16284748780-1f386c649-e311-0266-e053-dadaa90a7c1aDrug Facts
66267-643-302023-01-30C16284748780-1f386c649-e311-0266-e053-dadaa90a7c1aDrug Facts
66267-643-602023-01-30C16284748780-1f386c649-e311-0266-e053-dadaa90a7c1aDrug Facts
66267-643-982023-01-30C16284748780-1f386c649-e311-0266-e053-dadaa90a7c1aDrug Facts

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66267-64366267-643-30, 66267-643-60, 66267-643-02, 66267-643-98
51645-860

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
FRUCTOSE6YSS42VSEVIACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SORBITOL506T60A25RIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1fa71419-75e1-f739-e063-6294a90a573767dce48c-8e00-c6d0-e053-2991aa0a632e2024-08-14WarningsExact identifier
spl set id: 67dce48c-8e00-c6d0-e053-2991aa0a632e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.