Purpose
Magnesium hydroxide USP 600 mg........................................................................................Saline laxative
Dulcolax Chewy Bites Assorted Fruits Tablet, Chewable
FDA Label NDC 41167-0256
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 Chewy Bites Assorted Fruits (NDC 41167-0256). 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, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
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 and over | 4 chews (Up to 8 chews) |
| children 6 to under 12 years | 2 chews (Up to 4 chews) |
| children under 6 years | ask a doctor |
Other Information
● each chew contains: magnesium 250 mg, sodium 1 mg
● contains FD&C yellow no. 5 (tartrazine) as a color additive
● contains FD&C yellow no. 6
● store at 20°-25°C (68°-77°F)
Inactive Ingredients
ammonium hydroxide, carnauba wax, corn syrup, ethanol, ethyl acetate, FD&C blue no. 1, FD&C red no. 40, FD&C red no. 40 aluminum lake, FD&C yellow no. 5, FD&C yellow no. 5 aluminum lake, FD&C yellow no. 6, gum arabic, hydrogenated coconut oil, isopropanol, lecithin (soy), natural and artificial flavors, n-butanol, phosphoric acid, propylene glycol, shellac, sodium benzoate, sorbitol, sucrose, titanium dioxide, water, white beeswax
Questions?
Call 1-866-844-2798 or visit www.Dulcolax.com
Principal Display Panel
Dulcolax
Chewy fruit bites
30 Chewable bites
Assorted fruit
Principal Display Paneldulcolaxchewy Fruit Bites30 Chewable Bitesassorted Fruit (Dulcolax Chewy Fruit Bites Assorted Fruits 01)
Principal Display Paneldulcolaxchewy Fruit Bites30 Chewable Bitesassorted Fruit (Dulcolax Chewy Fruit Bites Assorted Fruits 02)
Principal Display Paneldulcolaxchewy Fruit Bites30 Chewable Bitesassorted Fruit (Dulcolax Chewy Fruit Bites Assorted Fruits 03)
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