Active Ingredient (In Each 15 Ml)
Magnesium hydroxide 1200 mg
Dulcolax Liquid
FDA Label NDC 41167-0291
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 (NDC 41167-0291). 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 active ingredient (in each 15 ml), 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., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Saline laxative
Use
● for relief of occasional constipation and 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 more than 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
● shake well immediately before each use
● for accurate dosing, use convenient pre-measured dose cup
● 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 30 mL to 60 mL
children 6 to under 12 years of age 15 mL to 30 mL
children 2 to under 6 years of age 5 mL to 15 mL
children under 2 years of age ask a doctor
Other Information
● each 15 mL contains:
calcium 20 mg, magnesium 595 mg, potassium 5 mg, sodium 3 mg
● do not use if safety seal is broken or missing
● close cap tightly after each use
● store at room temperature 20°-25°C (68°-77°F)
Inactive Ingredients
anhydrous citric acid, D&C red #28, flavor, glycerin, purified water, sorbitol, sucrose, xanthan gum
Questions?
Call 1-866-844-2798 or visit www.Dulcolax.com
Principal Display Panel
Dulcolax Liquid Saline Laxative - Cherry
Magnesium Hydroxide 1200 mg per 15 mL Saline Laxative
Stimulant-Free
12 Fl Oz (354 mL)
Dulcolax Liquid Saline Laxative (CherryMagnesium Hydroxide 1200 mg per 15 mL Saline LaxativeStimulant-Free12 Fl Oz (354 mL))
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