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| Product NDC Code | 54838-116 | ||||
|---|---|---|---|---|---|
| Drug Name | Silace |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1245686 | ||||
| Application Number | part334 | ||||
| Labeler Name | Lannett Company, 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: Docusate sodium 10 mg (in each 1 mL)
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 as indicated by doctor this product must be given in a 6 to 8 oz. glass of milk or fruit juice or infant's formula to prevent throat irritation. Dose may be taken as a single daily dose or in divided doses dosage should be adjusted to individual response higher doses are recommended for initial therapy the effect on stools is usually apparent 1 to 3 days after the first dose Adults and children over 12 years 50 to 200 mg (1 to 4 teaspoonful) Children 6 to under 12 years 50 to 100 mg (1 to 2 teaspoonful) Children 3 to under 6 years 25 to 50 mg(1/2 to 1 teaspoonful) Children under 3 years of age Ask a doctor
| Adults and children over 12 years | 50 to 200 mg (1 to 4 teaspoonful) |
| Children 6 to under 12 years | 50 to 100 mg (1 to 2 teaspoonful) |
| Children 3 to under 6 years | 25 to 50 mg(1/2 to 1 teaspoonful) |
| Children under 3 years of age | Ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, D&C red no. 33, flavor, methylparaben, Poloxamer, propylene glycol, propylparaben, purified water, sodium 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.Uses for gentle, reliable relief from 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.Silace Docusate sodium DOCUSATE SODIUM DOCUSATE ANHYDROUS CITRIC ACID D&C RED NO. 33 METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN SODIUM CITRATE WATER POLOXAMER 407 Lemon Vanilla Flavor
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.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.Other information store at room temperature 20°-25°C (68°-77°F) protect from freezing and excessive heat do not use if tamperevident safety seal around cap is broken or missing dispense in tight, light-resistant container with a child-resistant closure
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 doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that last over two weeks
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 888-974-5279 This product is not manufactured or distributed by Purdue Products LP, distributor of Colace® Liquid. Manufactured by: Silarx Pharmaceuticals, Inc. 1033 Stoneleigh Ave Carmel, NY 10512 USA
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
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.Warning Do not use laxative products for longer than 1 week unless told to do so by a doctor if you are presently taking mineral oil unless told to do 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