Tamper Evident Statement
Do not use if tamper evident twist-off cap is missing, broken or separated from neckring
Citroma Liquid
FDA Label NDC 11344-166
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nice-pak Products, Llc for the product Citroma (NDC 11344-166). 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 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Magnesium citrate 1.745g
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
- 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 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 between 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
Lemon Flavor
FORMUL BLENDED IN THE USA
10 FL OZ (296 mL)
Image Description (Mm01)
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