Citroma
FDA Label NDC 55312-667

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Western Family Foods, Inc for the product Citroma (NDC 55312-667). 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 active ingredient, purpose, use, warnings, ask a doctor, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Magnesium citrate 1.745 g per fl oz

Purpose

Saline Laxative

Use

for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours

Warnings

Do not use

  • if you are on a low salt diet

Ask A Doctor

before use if you have

  • kidney disease
  • a magnesium or sodium-restricted diet
  • abdominal pain, nausea or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
  • already use a laxative for a period longer than 1 week

Ask A Doctor Or Pharmacist Before Use If You Are

 taking any other drugs. 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 moverment after use. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding

ask a 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.

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 maximum 3 fl oz in 24 hours

    children under 2 years of age - ask a doctor

    discard unused product within 24 hours of opening bottle

Other Information

Other information

  • magnesium content 290 mg per 1 fl oz (30 mL)
  • sodium content 45 mg per 1 fl oz (30 mL)
  • store at temperatures between 46° and 86° F (8° and 30° C)

Inactive Ingredients

 citric acid, lemon oil, polyethylene glycol, purified water, sodium bicarbonate, sodium saccharin, sucrose

Questions Or Comments

1-800-525-2558

Adverse Reactions

Proudly Distribted by Western Family Foods, Inc.

P.O.Box 4057, Portland, OR 97208 U.S.A.

Copyright 2014 Marca Registrada

www. westernfamily.com

Principal Display Panel

WESTERN

FAMILY

Magnesium

Citrate

Saline Laxatixe

Oral Solution

TAMPER  EVIDENT:

DO NOT USE IF THE BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

10 FL OZ (296 mL)

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Image Description (Mm1)

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