FDA Label for Citroma

View Indications, Usage & Precautions

Citroma Product Label

The following document was submitted to the FDA by the labeler of this product Toppco. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Magnesium citrate 1.745g per fl oz


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)


* Please review the disclaimer below.