Magnesium Citrate — v1

Magnesium Citrate

6 Views

Version

v1

Effective date

September 30, 2025

Original packager

Yes

Sections captured

16

Identifiers

Document ID
4019f5bb-f9df-92fc-e063-6394a90aa042
Set ID
4019fbd0-fcf9-77a6-e063-6294a90a5ae7
Application numbers
M007
Product NDCs
69452-398
Package NDCs
69452-398-98
Original packager NDCs

Names & Manufacturers

Brand names
Magnesium Citrate
Generic names
MAGNESIUM CITRATE ORAL SOLUTION
Manufacturer names
Bionpharma, Inc.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
MAGNESIUM CITRATE
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
RHO26O1T9V
UPC
0369452398982

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active Ingredient Magnesium citrate 1.745g per fl oz
Ask Doctor (1)

Sequence 1

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.
Dosage And Administration (1)

Sequence 1

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
Dosage And Administration Table (1)

Sequence 1

adults and children 12 years of age and over 6.5 to 10 fl oz maximum10 fl oz in 24 hours
children 6 to under 12 years of age 3 to 7 fl oz maximum7 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 (1)

Sequence 1

Inactive Ingredients benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water
Indications And Usage (1)

Sequence 1

Uses ■ For relief of occasional constipation (irregularity). ■ Generally produces bowel movement in ½ to 6 hours
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Other Safety Information (2)

Sequence 1

Other Information Store at temperatures between 46° and 86°F (8° and 30° C)

Sequence 2

Other Information ■ each fl oz contains: magnesium 290 mg ■ each fl oz contains: sodium 1 mg
Package Label Principal Display Panel (1)

Sequence 1

10 fl oz bottle label • dye-free • sugar-free a+ health TM magnesium citrate saline laxative / oral solution alcohol content 0.025% (from flavoring) lemon flavor 10 fl oz (296 mL) bottle
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask health professional before use.
Purpose (1)

Sequence 1

Purpose Saline Laxtive
Questions (1)

Sequence 1

Questions? 1-888-235-2466
Spl Product Data Elements (1)

Sequence 1

Magnesium Citrate magnesium citrate oral solution BENZOIC ACID WATER CITRIC ACID MONOHYDRATE SUCRALOSE EDETATE DISODIUM ANHYDROUS MAGNESIUM CITRATE MAGNESIUM CATION
Spl Unclassified Section (1)

Sequence 1

Do not use if tamper evident twist-off cap is missing, broken, or separated from neckring Distributed by: Bionpharma Inc., Princeton, NJ 08540 L0001053 R0525
Stop Use (1)

Sequence 1

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.
Warnings (1)

Sequence 1

Warnings 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

OpenFDA raw payload

{'application_number': ['M007'],
 'brand_name': ['Magnesium Citrate'],
 'generic_name': ['MAGNESIUM CITRATE ORAL SOLUTION'],
 'is_original_packager': [True],
 'manufacturer_name': ['Bionpharma, Inc.'],
 'package_ndc': ['69452-398-98'],
 'product_ndc': ['69452-398'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'spl_id': ['4019f5bb-f9df-92fc-e063-6394a90aa042'],
 'spl_set_id': ['4019fbd0-fcf9-77a6-e063-6294a90a5ae7'],
 'substance_name': ['MAGNESIUM CITRATE'],
 'unii': ['RHO26O1T9V'],
 'upc': ['0369452398982']}