FDA Label for Citroma
View Indications, Usage & Precautions
- TAMPER EVIDENT STATEMENT
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN.
- STORAGE AND HANDLING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- DISCLAIMER
- ADVERSE REACTION
- PRINCIPAL DISPLAY PANEL
Citroma Product Label
The following document was submitted to the FDA by the labeler of this product Consumer Product Partners, 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.
Tamper Evident Statement
DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN, OR SEPERATED FROM NECKRING
Active Ingredient
Magnesium citrate 1.745g per fl oz
Purpose
Saline laxative
Uses
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.
Storage And Handling
Store at temperatures betweem 46° and 86°F (8° and 30° C)
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 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
children under 2 years of age - ask a doctor
Other Information
- each fl oz contains:magnesium 290 mg
- each fl oz contains:sodium 1 mg
Inactive Ingredients
benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water
Disclaimer
Non-USP; Non-Carbonated, Non-Pasteurized; Contains Preservatives
Adverse Reaction
Distributed by: Vi-Jon, LLC
One Swan Drive,
Smyrna, TN 37167
Principal Display Panel
swan ®
Magnesium Citrate
Saline Laxative
Oral Solution
Low Sodium
Cherry Flavor
FORMULA BLENDED IN THE USA
Citroma
MAGNESIUM CITRATE
10 FL OZ (296 mL)
* Please review the disclaimer below.