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Product NDC Code | 69842-195 | ||||||||
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Drug Name | Maximum strength laxative |
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Type | Brand | ||||||||
Active Ingredients |
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Route | ORAL | ||||||||
Dosage Form | TABLET, COATED | ||||||||
RxCUI drug identifier | 251292 | ||||||||
Application Number | part334 | ||||||||
Labeler Name | CVS HEALTH | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Each Tablet contains: CALCIUM SENNOSIDES 25 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 preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable. Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets twice a day Children 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a day Children 6 to under 12 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day Children under 2 years - Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide
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.ses: Relieves occasional constipation (irregularity); generally causes bowel movement in 6-12 hours
Purpose
Information about the drug product’s indications for use.stool softner, laxative
Spl product data elements
Usually a list of ingredients in a drug product.MAXIMUM STRENGTH LAXATIVE SENNOSIDES CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 FERROSOFERRIC OXIDE KAOLIN MALTODEXTRIN SENNOSIDES SENNOSIDES CALCIUM SULFATE ANHYDROUS CARNAUBA WAX MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STEARIC ACID RAW SUGAR TALC TITANIUM DIOXIDE SILICON DIOXIDE STARCH, CORN FERRIC OXIDE YELLOW POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE SHELLAC ACACIA TCL083
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.195R 250 COUNT
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 the reach of children. Incase of overdose, get medical help or contact a Poison Control Center right away.
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 this product If you are presently taking mineral oil, unless directed by a doctor Laxative products for longer than 1 week unless directed by a doctor
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