Citroma Liquid
FDA Label NDC 11344-164

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 11344-164). 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 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

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Magnesium Citrate

Saline Laxative

Oral Solution

Low Sodium

Cherry Flavor

FORMULA BLENDED IN THE USA

Citroma

MAGNESIUM CITRATE

10 FL OZ (296 mL)

Image Description (Mm01)

Image Description (Mm01)

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