FDA.reportPublic FDA data

ALMACONE DOUBLE STRENGTH

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2021-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:22:06

Label at a glance#

ProductALMACONE DOUBLE STRENGTH
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure8 sections

Indications and uses

relieves heartburn sour stomach acid indigestion symptoms referred to as gas

Dosage and administration

shake well before use adults and children 12 years of age and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor do not take more than 12 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks children under 12 years: ask a doctor

Storage and handling

each 5 mL teaspoonful contains: magnesium 165 mg, sodium 5 mg store at room temperature protect from freezing keep tightly closed

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide 400 mg (equivalent to dried gel, USP)
Magnesium hydroxide 400 mg
Simethicone 40mg

Purposes

OTC - PURPOSE SECTION

Antacid
Antigas

Uses

INDICATIONS & USAGE SECTION

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • symptoms referred to as gas

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

  • kidney disease
  • a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are taking a prescription drug.
Antacids may interact with certain prescription drugs.
Stop use and ask a doctor if symptoms last more than 2 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • adults and children 12 years of age and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor
  • do not take more than 12 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL teaspoonful contains: magnesium 165 mg, sodium 5 mg
  • store at room temperature
  • protect from freezing
  • keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-0015-83ML - Milliliter0536-001567151b8a-7e0f-42e4-8011-8579b7877f4c12013-02-13

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-260368071-2603-1
0536-0015

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLPARABEN3QPI1U3FV8IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
HYPROMELLOSES3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALMACONE DOUBLE STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONERUGBY LABORATORIES25f22cff-2864-4853-a7f8-8edd9f8f3c292023-11-02WarningsExact identifier
ndc (product): 0536-0015
0075774d-9b18-7e25-e063-6394a90a0fc1d39cc81a-13c0-55ea-e053-2a95a90ac2af2023-07-14WarningsExact identifier
spl set id: d39cc81a-13c0-55ea-e053-2a95a90ac2af

Reported adverse events (FAERS/openFDA)#

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