Active Ingredient
Magnesium citrate 1.745g per fl oz
Citroma Liquid
FDA Label NDC 36800-709
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Citroma (NDC 36800-709). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, ask a doctor, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Saline laxative
Use
- for relief of occasional constipation (irregularity).
- Generally produces bowel movement in 1/2 to 6 hours
Warnings
for this product
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
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.
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.
If Pregnant Or Breast-Feeding
ask help professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away
Store at temperatures between 46° and 86°F (8° and 30° C)
Directions
- 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 in 24 hours maximum 3 fl oz in 24 hours
children under 2 years of age - ask a doctor
Other Information
- each fl oz contains: magnesium 295 mg
- each fl oz contains: sodium 1 mg
Inactive Ingredients
benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water
Adverse Reaction
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
TOPCO VIJA0818
QUESTIONS? 1-888-423-0139
QUALITY GUARANTEED
[email protected] www.topcarebrand.com
166.000/166AA
Principal Display Panel
TopCare
health
NDC 36800-709-38
Magnesium
Citrate
OUR PHARMACISTS RECOMMEND
SALINE LAXATIVE
ORAL SOLUTION
Alcohol content 0.0125%
(from flavoring)
For Relief of Occasional Constipation
TAMPER EVIDENT: DO NOT SE IF THE BREAKAWAY BAND ON CAP IS BROKEN OR MISSING
LEMON FLAVOR
10 FL OZ (296 mL)
Image Description (Mm3)
* Please review the disclaimer below.
