OTC Medication Information: Magnesium Citrate

MAGNESIUM CITRATE- magnesium citrate solution
H E BUTT

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.

TEP

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

Active ingredient

Active ingredient in each fl oz

Magnesium citrate 1.745 g

Purpose

Saline Laxative

Uses

  • for relief of occasiona constipation (irregularity).
  • Generally produces bowel movement in 1/2 to 6 house

Warnings

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 if

You have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

If pregnant

If pregnant or breast-feeding, ask a health 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.

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 each dose
  • may be taken as a single dose or in a divided doses

adults and children 12 years of age and over — 6.5 — 10 fl oz maximum 10 fl oz in 24 hours

childrem 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

chidlren 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

Questions

Call? 1-888-593-0593

Adverse reactions

MADE WITH PRIDE & CARE FOR H-E-B

SAN ANTONIO, TX 78204

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H-E-B

Magnesium Citrate

Oral Solution

Saline Lazative

  • Relief of: Occasional Constipation

Sugar & Dye Free

Gluten Free

Cherry Flavor

10 FL OZ (296 mL)

image description
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MAGNESIUM CITRATE
magnesium citrate solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-673
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM CITRATE (MAGNESIUM CATION) MAGNESIUM CITRATE 0.059 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM ANHYDROUS
SUCRALOSE
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-673-38 296 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 08/17/2021
Labeler — H E BUTT (007924756)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (37808-673)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (37808-673)

Revised: 09/2022 H E BUTT

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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