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| Product NDC Code | 41167-0265 | ||||||||
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| Drug Name | Dulcolax soft chews mixed berry |
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| Type | Brand | ||||||||
| Pharm Class | Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | TABLET, CHEWABLE | ||||||||
| RxCUI drug identifier | 2280709 | ||||||||
| Application Number | 505G(a)(3) | ||||||||
| Labeler Name | Chattem, Inc. | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each chew )
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
| 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 |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn syrup, FD&C red no. 40, glycerin, hydrogenated coconut oil, lecithin (soy), natural flavor, sucrose, water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use ● for relief of occasional constipation (irregularity) ● this product generally produces bowel movement in ½ to 6 hours
Purpose
Information about the drug product’s indications for use.Purpose Magnesium hydroxide 1200 mg................................................................................................Saline laxative
Spl product data elements
Usually a list of ingredients in a drug product.Dulcolax Soft Chews Mixed Berry MAGNESIUM HYDROXIDE MAGNESIUM HYDROXIDE MAGNESIUM CATION CORN SYRUP FD&C RED NO. 40 GLYCERIN HYDROGENATED COCONUT OIL LECITHIN, SOYBEAN SUCROSE WATER Mixed Berry
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL Dulcolax Saline Laxative Soft Chews Mixed Berry 30 Soft chews PRINCIPAL DISPLAY PANEL Dulcolax Saline Laxative Soft Chews Mixed Berry 30 Soft chews
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Dulcolax® Soft Chews Saline Laxative – Mixed Berry Drug Facts
Other information ● each chew contains : magnesium 500 mg , sodium 2 mg ● store at room temperature 20°-25°C (68°-77°F)
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or p harmacist before use if you are taking a prescription drug. This product may interact with certain prescription drugs.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-866-844-2798 or visit www.Dulcolax.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 lasts over 2 weeks Ask a doctor or p harmacist 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API