Purpose
Magnesium hydroxide 1200 mg................................................................................................Saline laxative
Dulcolax Soft Chews Mixed Berry Tablet, Chewable
FDA Label NDC 41167-0265
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Dulcolax Soft Chews Mixed Berry (NDC 41167-0265). 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 purpose, use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
● for relief of occasional constipation (irregularity)
● this product generally produces bowel movement in ½ to 6 hours
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 lasts over 2 weeks
Ask A Doctor Or Pharmacist Before Use If You Are
taking a prescription drug. This product may interact with certain prescription drugs.
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
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 oz) of liquid with each 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 under 12 years of age 1 to 2 chews
children under 6 years of age ask a doctor
Other Information
● each chew contains: magnesium 500 mg, sodium 2 mg
● store at room temperature 20°-25°C (68°-77°F)
Inactive Ingredients
corn syrup, FD&C red no. 40, glycerin, hydrogenated coconut oil, lecithin (soy), natural flavor, sucrose, water
Questions?
Call 1-866-844-2798 or visit www.Dulcolax.com
Principal Display Panel
Dulcolax
Saline Laxative
Soft
Chews
Mixed Berry
30 Soft chews
Principal Display Paneldulcolaxsaline Laxativesoftchewsmixed Berry30 Soft Chews (Dulcolax Soft Chews Mixed Berry 01)
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