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| Product NDC Code | 41167-0101 | ||||||||||||||||||
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| Drug Name | Dulcolax simulant laxative |
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| Type | Brand | ||||||||||||||||||
| Pharm Class | Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||||||||
| Dosage Form | TABLET, FILM COATED | ||||||||||||||||||
| RxCUI drug identifier | 209613, 308753 |
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| 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 tablet) Bisacodyl (USP) 5 mg
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 take with a glass of water adults and children 12 years of age and over 1 to 3 tablets in a single daily dose children 6 to under 12 years of age 1 tablet in a single daily dose children under 6 years of age ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acacia gum, ammonium hydroxide, beeswax, carnauba wax, corn starch, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, glycerin, glyceryl monostearate, iron oxides, lactose monohydrate, magnesium stearate, methacrylic acid ethyl acrylate copolymer, methylparaben, modified starch, polyethylene glycol 6000, polysorbate 80, povidone, propylene glycol, propylparaben, shellac, sodium benzoate, sucrose, talc, titanium dioxide, triethyl citrate
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 and irregularity ● this product generally produces bowel movement in 6 to 12 hours
Purpose
Information about the drug product’s indications for use.Purpose Stimulant laxative
Spl product data elements
Usually a list of ingredients in a drug product.Dulcolax Simulant Laxative Bisacodyl BISACODYL DEACETYLBISACODYL ACACIA AMMONIA YELLOW WAX CARNAUBA WAX STARCH, CORN D&C RED NO. 30 D&C YELLOW NO. 10 GLYCERIN GLYCERYL MONOSTEARATE LACTOSE MONOHYDRATE FERRIC OXIDE RED MAGNESIUM STEARATE METHYLPARABEN POLYETHYLENE GLYCOL 6000 POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN SHELLAC SODIUM BENZOATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POVIDONE, UNSPECIFIED 12
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 OVERNIGHT RELIEF Dulcolax LAXATIVE 25 comfort coated Tablets PRINCIPAL DISPLAY PANEL OVERNIGHT RELIEF Dulcolax LAXATIVE 25 comfort coated Tablets
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® Stimulant Laxative Tablets Drug Facts
Other information ● do not use if individual blister unit is open or torn ● store at 20°-25°C (68°-77°F) ● protect from excessive humidity
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 ● stomach pain, nausea or vomiting ● noticed a sudden change in bowel habits that lasts more than 2 weeks
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use ● if you cannot swallow without chewing
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 Keep carton as it contains important product information.
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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product ● it may cause stomach discomfort, faintness and cramps ● do not chew or crush tablet(s) ● do not use within 1 hour after taking an antacid or milk
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 Do not use ● if you cannot swallow without chewing Ask a doctor before use if you have ● stomach pain, nausea or vomiting ● noticed a sudden change in bowel habits that lasts more than 2 weeks When using this product ● it may cause stomach discomfort, faintness and cramps ● do not chew or crush tablet(s) ● do not use within 1 hour after taking an antacid or milk 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