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citroma

CVS 166.000/166AA rev1 - AB Lemon Magnesium Citrate

Approved
Approval ID

498acb19-b2f4-4af0-8996-390115c17fe0

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

CVS Pharmacy

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

NDC Product Code69842-983
Application NumberM007
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 21, 2025
Generic NameMagnesium Citrate

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: 5/21/2025

Principal display panel

CVS Health ®

Magnesium Citrate

SALINE LAXATIVE

Oral solution

Non-pasteurized

DYE FREE

Lemon 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

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
  • abdorominal 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: 5/21/2025

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 between 46° and 86°F (8° and 30°C)

DOSAGE & ADMINISTRATION SECTION

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

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

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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