OTC Medication Information: Citroma

CITROMA- magnesium citrate liquid
Cariba International

Disclaimer: 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.

Active ingredient

Magnesium citrate 1.745 g per fl oz

Purpose

Saline Laxative

Use

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

Warnings

for this product

Ask a doctor before use

If you have

  • kidney disease
  • a magnesium or potassium-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 durgs. Laxatives may affect how other durgs 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 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 dose or in divided doses

Adults and children 12 years 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

  • each fl oz contains: magnesium 290 mg
  • ´╗┐each fl oz contains: potassium 80 mg

inactive ingredients

citric acid, lemon oil, potassium bicarbonate, water purified, sodium saccharin

Adverse reactions

Distributed by:

Cariba International

P.O. Box 1208

Safety Harbor, Florida 34695

MADE IN USA WITH US AND FOREIGN COMPONENTS

Principal display panel

CARIBA

MAGNESIUM CITRATE

SALINE LAXATIVE

ORAL SOUTION

PLEASING LEMONY FLAVOR

PASTEURIZED

VERH LOW SODIUM

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

10 FL OZ (296 mL)

image description
(click image for full-size original)
CITROMA
magesium citrate liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67860-686
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM CITRATE (MAGNESIUM CATION) MAGNESIUM CITRATE 1.745 g in 29.61 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
LEMON OIL
POTASSIUM BICARBONATE
water
SACCHARIN SODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67860-686-38 296 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 12/20/2016
Labeler — Cariba International (049354067)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (67860-686)

Revised: 05/2022 Cariba International

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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