FDA.reportPublic FDA data

Gentle Laxative

Manufacturer
MEIJER, INC. | GCP Laboratories
Effective date
2024-05-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:12:52

Label at a glance#

ProductGentle Laxative
Active ingredientMAGNESIUM HYDROXIDE
Label structure8 sections

Dosage and administration

shake well before use do not exceed the maximum recommended daily dose in a 24 hour period dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor follow each dosage with a full glass (8 oz) of liquid adults and children 12 years and older 30 mL to 60 mL children 6 to 11 years 15 mL to 30 mL children under 6 years ask a doctor

Storage and handling

each 15 mL contains: magnesium 500 mg, sodium 6 mg store at room temperature tightly closed do not freeze

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Magnesium hydroxide 1200 mg

Purpose

OTC - PURPOSE SECTION

Saline laxative

Use

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 1/2 to 6 hours

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

  • kidney disease
  • a magnesium-restricted diet
  • stomach pain, nausea, or vomiting
  • a sudden change in bowel habits that lasts over 14 days

Ask a doctor or pharmacist before use if you are taking a prescription drug. This product may interact with certain prescription drugs.

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

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. In case of overdose, get medical help
or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • do not exceed the maximum recommended daily dose in a 24 hour period
  • dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor
  • follow each dosage with a full glass (8 oz) of liquid
adults and children 12 years and older30 mL to 60 mL
children 6 to 11 years15 mL to 30 mL
children under 6 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: magnesium 500 mg, sodium 6 mg
  • store at room temperature tightly closed
  • do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid, D&C red no. 28, flavor, glycerin,
microcrystalline cellulose, purified water, sodium citrate, sodium hypochlorite, sucrose, xanthan gum

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
253017magnesium hydroxide 1200 MG in 15 mL Oral SuspensionPSN2
253017magnesium hydroxide 80 MG/ML Oral SuspensionSCD2
253017magnesium hydroxide 1200 MG per 15 ML Oral SuspensionSY2
253017milk of magnesia 2400 MG per 30 ML Oral SuspensionSY2
253017milk of magnesia 400 MG per 5 ML Oral SuspensionSY2
253017milk of magnesia 8 % Oral SuspensionSY2
253017milk of magnesia 80 MG/ML Oral SuspensionSY2

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
79481-0195-1Gentle Laxative355 mL in 1 BOTTLELIQUID3552

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0195GENTLE LAXATIVE (MAGNESIUM HYDROXIDE) LIQUID [MEIJER, INC.]2Current NDC, 1 package rows20240524_11fe5bd0-585a-ad8a-e063-6294a90a3ae8.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79481-019579481-0195-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
WATER059QF0KO0RIACT
SODIUM HYPOCHLORITEDY38VHM5ODIACT
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
D&C RED NO. 28767IP0Y5NHIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCROSEC151H8M554IACT
XANTHAN GUMTTV12P4NEEIACT

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
Gentle LaxativeMAGNESIUM HYDROXIDEMEIJER, INC.11fe5bd0-585a-ad8a-e063-6294a90a3ae82024-05-22WarningsExact identifier
ndc (package): 79481-0195-1
ndc (product): 79481-0195
ndc11 (package): 79481019501
spl id: 190f03f1-d79b-d775-e063-6294a90a3b71
spl set id: 11fe5bd0-585a-ad8a-e063-6294a90a3ae8

Reported adverse events (FAERS/openFDA)#

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