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| Product NDC Code | 48433-220 | ||||
|---|---|---|---|---|---|
| Drug Name | Docusate sodium |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1248119 | ||||
| Application Number | part334 | ||||
| Labeler Name | Safecor Health, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each 5 mL = 1 teaspoonful) 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: * Must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation * Shake well before using * Do not exceed recommended dose * May be taken in one to four equally divided oral doses each day * Take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response Adults and children 12 years of age and over 5 mL (1 teaspoon) to 40 mL (8 teaspoons) or as directed by a doctor Children 6 to 12 years of age 4 mL to 15 mL (3 teaspoons) or as directed by a doctor Children 3 to 6 years of age 2 mL to 6 mL or as directed by a doctor Children under 3 years of age 1 mL to 4 mL or as directed by a doctor 1 teaspoon = 5 mL Other information: Each teaspoon (5 mL) contains: sodium 5 mg. Store at room temperature 20°C-25°C (68°F-77°F); excursions between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light. For more info call 1-800-447-1006. Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, and sucralose. NDC: 48433-220-10 Docusate Sodium Liquid 100 mg/10 mL Unit Dose Cup Mfd. in the U.S.A. Distributed by: Safecor Health, LLC 4060 Business Park Drive, Columbus, OH 43204 Rev: 11/2020 PN5473 3 4843322010 8
| Adults and children 12 years of age and over | 5 mL (1 teaspoon) to 40 mL (8 teaspoons) or as directed by a doctor |
| Children 6 to 12 years of age | 4 mL to 15 mL (3 teaspoons) or as directed by a doctor |
| Children 3 to 6 years of age | 2 mL to 6 mL or as directed by a doctor |
| Children under 3 years of age | 1 mL to 4 mL or as directed by 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, purified water, sodium benzoate, sodium citrate, and sucralose. NDC: 48433-220-10 Docusate Sodium Liquid 100 mg/10 mL Unit Dose Cup Mfd. in the U.S.A. Distributed by: Safecor Health, LLC 4060 Business Park Drive, Columbus, OH 43204 Rev: 11/2020 PN5473 3 4843322010 8
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: 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 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.Principal Display Panel - Box Label SAFECOR HEALTH Docusate Sodium Liquid 100 mg / 10 ml Contains 40 (10 ml) Unit Dose Cups See monograph for complete drug information. NDC: 48433-220-40 QTY: 40 Lot: 21A0079 Exp: 2023-03-31 Store at room temperature 20°C-25°C (68°F-77°F); excursions between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light. This package design is not child resistant. For institutional use only. Shake well before use. 3 48433 22040 5 Pkg By: Safecor Health, LLC Columbus, OH 43204 Questions or Comments: Call 1-800-447-1006 GTIN: 00348433220405 SN: 212802331 Exp; 2023-03-31 Lot 21A0079 PN5689.C Principal Display Panel - Box Label
Principal Display Panel - Lid Label Delivers 1 0 mL NDC 48433-220-10 Docusate Sodium Liquid 100 mg/10mL SHAKE WELL 348433220108 Pkg By: Safecor Health, LLC Columbus, OH 43204 PN5618.B Principal Display Panel - Lid Label
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 noticed a sudden change in bowel habits that persist over a period of 2 weeks * are taking mineral oil
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 * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed 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 this and all drugs out of reach of children . In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information: Each teaspoon (5 mL) contains: sodium 5 mg. Store at room temperature 20°C-25°C (68°F-77°F); excursions between 15°C-30°C (59°F-86°F) are allowed. Protect from excessive heat. Protect from light. For more info call 1-800-447-1006.
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 failure to have a bowel movement within 3 days. These could be signs of a serious condition. * a skin rash occurs * you experience throat irritation
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding , ask a health care 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 * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed by a doctor Ask a doctor before use if you * have noticed a sudden change in bowel habits that persist over a period of 2 weeks * are taking mineral oil Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 3 days. These could be signs of a serious condition. * a skin rash occurs * you experience throat irritation If pregnant or breast feeding , ask a health care professional before use. Keep this and all drugs out of reach of children . In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water.
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