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 Carbia International. 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 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 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 Cariba International
P.O. Box 1208 Safety Harbor
Harbor, Florida 34695
166.000/166AA
Principal Display Panel
CARIBA
CARE
Magnesium
Citrate
SALINE LAXATIVE
ORAL SOLUTION
Lemon Flavor
Non-Pasteurized
Very Low Sodium
Alcohol content 0.012% (from flavoring)
DO NOT USE IF TAMPER EVIDENT TWIST-OF CAP IS MISING, BROKEN OR SEPARATED FROM NECKRING
10 FL OZ (296 mL)
* Please review the disclaimer below.