FDA.reportPublic FDA data

REGULAR STRENGTH ANTACID

Manufacturer
AMERISOURCEBERGEN DRUG CORPORATION | GCP Laboratories
Effective date
2023-11-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:18

Label at a glance#

ProductREGULAR STRENGTH ANTACID
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure9 sections

Indications and uses

relieves heartburn sour stomach acid indigestion the symptoms referred to as gas

Dosage and administration

shake well before use adults and children 12 years of age and older: take 10 mL to 20 mL (1 to 2 doses) between meals as needed, at bedtime, or as directed by a doctor children under under 12 years: ask a doctor

Storage and handling

each 10 mL dose contains: magnesium 165 mg, sodium 6 mg store at room temperature tightly closed do not freeze

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide 400mg (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
  • the symptoms referred to as gas

Warnings

WARNINGS SECTION

Do not take more than 80 mL (8 doses) in a 24 hour period or use the
maximum dosage for more than 2 weeks.

Ask a doctor before use if you have

• kidney disease
• a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are presently taking a

prescription drug. Antacids may interact with certain prescription drugs.

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

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 10 mL to 20 mL (1 to 2 doses) between meals as needed, at bedtime, or as directed by a doctor
  • children under under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL dose contains: magnesium 165 mg, sodium 6 mg
  • store at room temperature tightly closed
  • do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307746aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral SuspensionPSN4
307746aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral SuspensionSCD4
307746aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral SuspensionSY4
307746aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral SuspensionSY4
307746aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral SuspensionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-434-40REGULAR STRENGTH ANTACID355 mL in 1 BOTTLELIQUID3554

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-434REGULAR STRENGTH ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) LIQUID [AMERISOURCEBERGEN DRUG CORPORATION]4Current NDC, Legacy NDC, 1 package rows20231108_5d68366d-fee9-2acf-e053-2991aa0a7e4b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-434-40ML - Milliliter46122-4343dc349fd-5012-4e14-b6eb-9971ebd5aa4d12018-04-19

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46122-43446122-434-40

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
HYPROMELLOSES3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
BUTYLPARABEN3QPI1U3FV8IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL SOLUTION8KW3E207O2IACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
DIMETHICONE92RU3N3Y1OACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT

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
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d68366d-fee9-2acf-e053-2991aa0a7e4b2023-11-07WarningsExact identifier
ndc (package): 46122-434-40
ndc (product): 46122-434
ndc11 (package): 46122043440
spl id: 09937f20-1e6d-5b50-e063-6394a90a133d
spl set id: 5d68366d-fee9-2acf-e053-2991aa0a7e4b

Reported adverse events (FAERS/openFDA)#

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