Citroma Liquid
FDA Label NDC 11344-162

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 11344-162). 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 trp, active ingredient (in each fl oz), purpose, uses, warnings, ask a doctor, ask a doctor or pharmacist, stop use and ask a doctor i, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Trp

Do Not User If Tamper Evident Twist-off Cap Is Missing, Broken or Separated From Neckband

Active Ingredient (In Each Fl Oz)

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 I

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

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

Claims

Non-USP: Non-Carbonated, Non-Pasteurized; Contains Preservatives

Adverse Reaction

Distributed by: Consumer Product Partners, LLC

One Swan Drive,

Smyrna, TN 37167

Principal Display Panel

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Magnesium Citrate

Saline Laxative

Oral Solution

Low Sodum Grape Flavor

FORMULA BLENDED IN THE USA

10 FL OZ (296 mL)

Image Description (Mm01)

Image Description (Mm01)

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