FDA Label for Saline Laxative
View Indications, Usage & Precautions
Saline Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Magnesium citrate 1.745g per fl oz
Purpose
Saline laxative
Use
for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours
Warnings
for this product
Ask A Doctor
before use if you have
- kidney disease
- a magnesium restricted diet
- abdorominal 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 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
Store at temperatures between 46° and 86°F (8° and 30° C)
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 in 24 hours
children under 2 years of age - ask a doctor
Other Information
- each fl oz contains: magnesium 295 mg
- each fl oz contains: sodium 1 mg
Inactive Ingredients
benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water
Questions Or Comments?
(800)616-2471
Adverse Reaction
Distributed by: MAJOR PHARMACEUTICALS
17177 N Laurel Park Drive, Suire 233
Livonia, MI 48152
Re-Order No.014432 M-97
Rev. 10/16
Principal Display Panel
MAJOR
Magnesium Citrate
Saline Laxative
Lemon Flavored
Alcohol content 0.012% from flavoring
DO NOT UISE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING
10 FL OZ (296 mL)
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