Magnesium Citrate Saline Laxative - Cherry Flavor Solution
FDA Label NDC 52000-451
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Magnesium Citrate Saline Laxative - Cherry Flavor (NDC 52000-451). 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 drug facts, active ingredient (in each fl oz), purpose, uses:, warnings:, otc - keep out of reach of children, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Fl Oz)
Magnesium citrate 1.745 g
Purpose
Saline laxative
Uses:
• For relief of occasional constipation (irregularity).
• Generally produces bowel movement in ½ to 6 hours
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 or breast-feeding, ask a health professional before use.
Otc - 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:
• shake well before using • drink a full glass (8 ounces) of liquid each dose • may be taken as a single 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 |
Other Information:
• each fl oz contains: magnesium 290 mg
• each fl oz contains: sodium 1 mg
store at temperatures between 46° and 86°F (8° and 30°C)
Inactive Ingredients:
benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water
Packaging
Magnesium Citrate (52000451 3)
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