MedPath

Citroma

Citroma 166.000/166AA rev 1-AB Lemon Magnesium Citrate

Approved
Approval ID

f28a9043-e0ee-4b38-95d9-d3f23d400691

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 12, 2025

Manufacturers
FDA

UpLift Brands, LLC

DUNS: 119091527

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Magnesium Citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83986-166
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Magnesium Citrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 12, 2025
FDA Product Classification

INGREDIENTS (6)

BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM CITRATEActive
Quantity: 1.745 g in 29.6 mL
Code: RHO26O1T9V
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/12/2025

Principal display panel

CITROMA ®

MAGNESIUM CITRATE

SALINE LAXATIVE

ORAL SOLUTION

LEMON FLAVOR

Do not use if tamper evident twist-off cap is missing, broken or separated from necking

10 FL OZ (296 mL)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/12/2025

Uses

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

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 5/12/2025

Adverse Reaction

Distributed by:

UpLift Brands, LLC

St. Louis, MO 63114

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/12/2025

Active Ingredient (in each fl oz)

Magnesium citrate 1.745 g

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/12/2025

Purpose

Saline laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 5/12/2025

Warnings

for this product

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 5/12/2025

If pregnant or breast-feeding,

ask help professional before use.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/12/2025

Ask A Doctor before use if you have

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 5/12/2025

Ask a doctor or pharmacist before use if you are

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/12/2025

Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/12/2025

Keep out of reach of children.

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/12/2025

Storage

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/12/2025

Directions

  • 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 oz maximum 3 fl oz in 24 hours

children under 2 years of age - ask a doctor

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/12/2025

other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/12/2025

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/12/2025

Questions?

Call 1-866-694-3769

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/12/2025

Disclaimer

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

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Citroma - FDA Drug Approval Details