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citroma

CVS 164.000/164AA rev 2 - 164AB Cherry Magnesium Citrate

Approved
Approval ID

15a9996d-7391-41f8-ab15-27ee2a6a60e4

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

CVS

DUNS: 062312574

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 Code69842-647
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Magnesium Citrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2025
FDA Product Classification

INGREDIENTS (6)

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
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/21/2025

Principal Display Panel

CVS Health ®

Magnesium Citrate

SALINE LAXATIVE

Oral solution

Non-pasteurized

DYE FREE

Cherry Flavor

10 FL OZ (296 mL)

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/21/2025

Uses

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

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 5/21/2025

ADVERSE REACTION

Distributed by: CVS Pharmacy, Inc

One CVS Drive, Woonsocket, RI 02895

@ 2023 CVS/pharmacy CVS.com ®

1-800-SHOP CVS

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 5/21/2025

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: 5/21/2025

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 - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 5/21/2025

If pregnant or breast-feeding,

ask health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/21/2025

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: 5/21/2025

Storage

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/21/2025

other information

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/21/2025

Active ingredient (in each fl oz)

Magnesium citrate 1.745 g

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/21/2025

Purpose

Saline laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 5/21/2025

Warnings

for this product

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/21/2025

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/21/2025

Directions

  • shake well first
  • 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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/21/2025

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/21/2025

Disclaimer

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

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citroma - FDA Drug Approval Details