Otc - Active Ingredient
Active ingredient (in each chew)
Magnesium Hydroxide USP 1200 mg
Cvs Magnesium Hydroxide Laxative Chew Tablet, Chewable
FDA Label NDC 51316-083
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Cvs Magnesium Hydroxide Laxative Chew (NDC 51316-083). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - ask doctor/pharmacist, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Saline laxative
Indications & Usage
Uses
- for relief of occasional constipation (irregularity)
- this product generally produces bowel movement in 1/2 to 6 hours
Warnings
Warnings
Ask a doctor before use if you have
- kidney disease
- a magnesium-restricted diet
- stomach pain, nausea or vomiting
- noticed a sudden change in bowel habits that last over 2 weeks
- Do not give to children under 5 years of age unless directed by a doctor
Otc - Stop Use
Stop use and ask a doctor if
- you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug. This product may interact with certain prescription drugs.
Otc - Pregnancy Or Breast Feeding
If you are pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- drink a full glass (8 oz) of liquid with wach dose
- dose may be taken as a single daily dose or in divided doses
- do not exceed the maximum recommended daily dose in a 24 hour period
- adults and children 12 years of age and over - 2 to 4 chews
- children 6 to 12 years of age - 1 to 2 chews
- children under 6 years of age - ask a doctor
Other Safety Information
Other information
- Each chew contains: magnesium 500 mg
- Contains soy
- Calories: 15 per chew
- Store between 20° to 25°C (68° to 77°F) in a dry place
- Do not use if bag is torn or open
Inactive Ingredient
Inactive ingredients: Confectioner's sugar, corn syrup, corn syrup solids, FD&C red no. 40 aluminum lake, glycerin, gum arabic. hydrogenated coconut oil, maltodextrin, natural flavors, propylene glycol, soy lecithin, sucrose, water.
Otc - Questions
Questions? Or to report an adverse event call 1-800-245-2898, Monday - Friday, 9AM - 4PM EST
* Please review the disclaimer below.
