Your browser does not support JavaScript! CITROMA (MAGESIUM CITRATE) LIQUID [MAJOR PHARMACEUTICALS]
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CITROMA (magesium citrate) liquid
[Major Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active ingredient

Active Ingredient

Magnesium citrate 1.745g per fl oz

Purpose

Purpose

Saline laxative

use

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

Warnings

Warnings

Do not use

Do not use if you are on a low salt diet

Ask A Doctor

Ask a doctor before use if you have

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

Ask a doctor or pharmacist

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

Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement afte use. These could be signs of a serious condition.

if pregnant or breast-feeding

If pregnant or breast-feeding, ask help professional before use.

Keep out of reach of children.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Directions

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 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

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 45mg per 1 fl oz (30 mL)
  • store at temperatures between 46º and 86º F (8º and 30º C)

Inactive ingredients

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

Questions

Questions or Comments? 1-800-616-2471

Adverse Reaction

Distributed By: MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA

Principal display panel

NDC 0904-6304-77

MAJOR

Magnesium Citrate

Oral solution

Lemon flavored

Effervescent saline laxative

DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING

10 FL OZ (296 mL)

image description

CITROMA 
magesium citrate liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0904-6304
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM CITRATE (MAGNESIUM CATION) MAGNESIUM CITRATE1.745 g  in 29.6 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
LEMON OIL 
POTASSIUM BICARBONATE 
SACCHARIN SODIUM 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6304-77296 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33408/27/2012
Labeler - Major Pharmaceuticals (191427277)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(0904-6304)

Revised: 3/2013
 
Major Pharmaceuticals

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