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Product NDC Code | 0536-1304 | ||||
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Drug Name | Docusate sodium liquid |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 1248119 | ||||
Application Number | part334 | ||||
Labeler Name | RUGBY LABORATORIES | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (per 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 follow dosing directions below or use as directed by a physician must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation may be taken as a single daily dose or in dividend dose take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response do not exceed recommended dose shake well before using 1 teasponnful = 5 mL Age Dose Adults and children over 12 years of age 1 to 6 teaspoons (50 mg - 300 mg) Children under 12 years of age Ask a doctor
Age | Dose |
Adults and children over 12 years of age | 1 to 6 teaspoons (50 mg - 300 mg) |
Children under 12 years of age | Ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, sodium benzoate, sodium citrate, sucralose
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 Relief of occasional constipation
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 Liquid Docusate Sodium DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 METHYLPARABEN POLOXAMER 124 POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM BENZOATE SODIUM CITRATE SUCRALOSE
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.DocusateSodium
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 accidental overdose, seek medical assistance 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? 1-800-645-2158
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a doctor 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 when abdominal pain, nausea, or vomiting are present unless directed by a doctor for more than one week unless directed by a doctor Ask a doctore before use if you are taking mineral oil have noticed a sudden change in bowel habits that last more than two weeks Stop use and ask doctor if you have no bowel movements within 3 days you have rectal bleeding these could be signs of a serious condition a skin rash occurs you experience throat irritation
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