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 Strategic Sourcing Services Llc. 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
  • 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

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 health 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 betweem 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 ozmaximum 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 McKesson

One Post Street, San Francisco, CA 94104

Money Back Guarantee

164.000/164AA rev 1


Principal Display Panel



sunmark

NDC 401677-0053-71

DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING

magnesium citrate Saline Laxative Oral Solution

Alcohol content 0.0205% (from flavoring)

Non-pasteurized

Saccharin free

Break resistant

Very low sodium

BPA free

CHERRY FLAVOR

Distributed By McKesson

One Post Street, San Francisco, CA 94104

Money Back Guarantee

10 FL OZ (296 mL)


* Please review the disclaimer below.