FDA.reportPublic FDA data

citroma

Manufacturer
Retail Business Services, LLC | Nice-Pak Products, LLC
Effective date
2026-02-06
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:37:23

Label at a glance#

Productcitroma
Active ingredientMAGNESIUM CITRATE
Label structure16 sections

Indications and uses

for relief of occasional constipation (irregularity).  Generally produces bowel movement in 1/2 to 6 hours

Dosage and administration

shake well before using drink a full glass (8 ounces) of liquid with each dose may be taken as a single daily dose or in divided doses adults and children 12 years of age and over - 6.5 to 10 fl oz maximum 10 fl oz in 24 hours children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hours children 2 to under 6 years of age - 2 to 3 fl ozmaximum 3 fl oz in 24 hours children under 2 years of age - as...

Storage and handling

Store at temperatures betweem 46° and 86°F (8° and 30°C)

Label contents#

Full prescribing information#

Active Ingredient (in each fl oz)

OTC - ACTIVE INGREDIENT SECTION

Magnesium citrate 1.745 g 

Purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation (irregularity). 
  • Generally produces bowel movement in 1/2 to 6 hours

Warnings

WARNINGS SECTION

for this product

Ask A Doctor before use if you have

OTC - ASK DOCTOR SECTION

  • kidney disease
  • a magnesium restricted diet
  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
  • already used a laxative for a period longer than 1 week

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking any other drug. 
  • Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Other information

STORAGE AND HANDLING SECTION

Store at temperatures betweem 46° and 86°F (8° and 30°C)

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • drink a full glass (8 ounces) of liquid with each dose
  • may be taken as a single daily dose or in divided doses

adults and children 12 years of age and over - 6.5 to 10 fl oz maximum 10 fl oz in 24 hours

children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hours

children 2 to under 6 years of age - 2 to 3 fl ozmaximum 3 fl oz in 24 hours

children under 2 years of age - ask a doctor

other information

OTHER SAFETY INFORMATION

  • each fl oz contains: magnesium 290 mg
  • each fl oz contains: sodium 1 mg

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water

Questions?

OTC - QUESTIONS SECTION

Call 1-833-992-3872

ADVERSE REACTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147

For product questions or concerns, contact us at 1-833-992-3872

Quality guaranteed or your money back.

Non-USP: Non-Carbonated, Non-Pasteurized; Contains Preservatives

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREONE ®

MAGNESIUM CITRATE

Saline Laxative

Cherry Flavor

DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING

NET 10 FL OZ (296 mL)

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
72476-002-38citroma296 mL in 1 BOTTLE, PLASTICLIQUID2968

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-00272476-002-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOIC ACID8SKN0B0MIMIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT
MAGNESIUM CITRATERHO26O1T9VACTIB

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
citromaMAGNESIUM CITRATERetail Business Services, LLCf3661952-ef4f-4f29-93e6-ec09b84643652026-02-06Warnings, Adverse reactionsExact identifier
ndc (package): 72476-002-38
ndc (product): 72476-002
ndc11 (package): 72476000238
spl id: 4a2b1261-6a75-c111-e063-6394a90a8dfd
spl set id: f3661952-ef4f-4f29-93e6-ec09b8464365

Reported adverse events (FAERS/openFDA)#

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