FDA.reportPublic FDA data

Mi-Acid Gas Relief

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:00:16

Label at a glance#

ProductMi-Acid Gas Relief
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

relieves: pressure bloating symptoms referred to as gas

Dosage and administration

chew 2 to 4 tablets thoroughly as needed after meals and at bedtime. do not exceed 6 tablets per day unless directed by a physician.

Storage and handling

do not use if inner seal is broken. store at room temperature avoid high humidity and excessive heat, above 40 0 C (104 0 F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 80 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

relieves:

  • pressure
  • bloating
  • symptoms referred to as gas

Warnings

WARNINGS SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew 2 to 4 tablets thoroughly as needed after meals and at bedtime.
  • do not exceed 6 tablets per day unless directed by a physician.

Other information

STORAGE AND HANDLING SECTION

  • do not use if inner seal is broken.
  • store at room temperature
  • avoid high humidity and excessive heat, above 40 0C (104 0F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

Call (800) 616-2471

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5136-32024-06-21C16284748780-1ba0f9c33-210e-a910-e053-dadaa90a0b85Mi-Acid Gas Relief
68071-5136-32023-01-30C16284748780-1ba0f9c33-210e-a910-e053-dadaa90a0b85Mi-Acid Gas Relief
68071-5136-32021-02-22C16284748780-1ba0f9c33-210e-a910-e053-dadaa90a0b85Mi-Acid Gas Relief
68071-5136-32021-01-29C16284748780-1ba0f9c33-210e-a910-e053-dadaa90a0b85Mi-Acid Gas Relief

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5068-60EA - Each0904-50686f3055e0-6cdc-44ea-9134-ca80b5c7bb0612013-02-13

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
68071-513668071-5136-3
0904-5068

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
SUCROSEC151H8M554IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SORBITOL506T60A25RIACT
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
362349bf-2340-08fe-e063-6394a90a609c99ec73c1-6493-5efa-e053-2a95a90a7a292025-05-27WarningsExact identifier
spl set id: 99ec73c1-6493-5efa-e053-2a95a90a7a29

Reported adverse events (FAERS/openFDA)#

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