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| Product NDC Code | 55154-2346 | ||||
|---|---|---|---|---|---|
| Drug Name | Docusate sodium |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1245686 | ||||
| Application Number | M007 | ||||
| Labeler Name | Cardinal Health 107, LLC | ||||
| 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 5 mL) Docusate sodium 50 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 • Dose once daily • take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste. adults and children 12 years and older 5 to 20 mL (1 to 4 teaspoonfuls) children 6 to under 12 years of age 5 to 10 mL (1 to 2 teaspoonfuls) children 3 to under 6 years of age 2.5 to 5 mL (1/2 to 1 teaspoonful) children under 3 years ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients artificial cherry vanilla flavoring, citric acid anhydrous, D&C Red No. 33, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol.
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.Uses • relieves occasional constipation (irregularity) • generally produces bowel movement in 12 to 72 hours
Purpose
Information about the drug product’s indications for use.Purpose Stool softener
Spl product data elements
Usually a list of ingredients in a drug product.Docusate Sodium Docusate Sodium DOCUSATE SODIUM DOCUSATE ANHYDROUS CITRIC ACID D&C RED NO. 33 GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SACCHARIN SODIUM SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SOLUTION Clear pink to purple-pink Cherry-Vanilla
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 DOCUSATE SODIUM LIQUID 100 MG / 10 mL 5 CUPS 100mg/10mL bag label
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.Drug Facts
R06/22 Distributed by: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 Distributed By: Cardinal Health Dublin, OH 43017 L58458960724
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 • vomiting • noticed a sudden change in bowel habits that lasts over 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 are presently taking mineral oil, unless told to do so by a doctor
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 or comments? Call 1-800-845-8210
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 use of a laxative. These could be signs of a serious condition. • you need to use a stool softener laxative for more than 1 week • rash occurs
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information • • Sodium content: 14 mg/ 5 mL • Store at controlled room temperature, 20° to 25°C (68° to 77°F) • Protect from freezing • Protect from light • Clear pink to purple-pink colored, cherry flavored liquid supplied in the following: Overbagged with 5 x 10 mL unit dose cups in each bag, NDC 55154-2346-5
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 are presently taking mineral oil, unless told to do so by a doctor Ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. • you need to use a stool softener laxative for more than 1 week • rash occurs 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