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| Product NDC Code | 0132-0107 | ||||
|---|---|---|---|---|---|
| Drug Name | Pedia-lax |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1088245, 1088249 |
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| Application Number | part334 | ||||
| Labeler Name | C.B. Fleet 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 Ingredients (in each 15 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 do not give more than 45 mL in any 24 hour period use only with enclosed dosing cup find right dose on chart below mL = milliliter Age Dose Children 2 to under 12 years 15 mL to 45 mL; do not take more than 45 mL in 24 hours Children under 2 years ask a doctor Doses can be diluted in a suitable beverage to prevent throat irritation and to help mask the naturally tart flavor of the active ingredient (see side panel for info).
| Age | Dose |
| Children 2 to under 12 years | 15 mL to 45 mL; do not take more than 45 mL in 24 hours |
| Children under 2 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients citric acid, edetate disodium, flavor, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, sodium citrate, sorbitol, sucralose, water, xanthan gum, xylitol
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 prevention of dry, hard stools for relief of occasional constipation this product usually produces a 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.Pedia-Lax Docusate Sodium DOCUSATE SODIUM DOCUSATE CITRIC ACID MONOHYDRATE EDETATE DISODIUM METHYLPARABEN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL PROPYLPARABEN SODIUM CITRATE SORBITOL SUCRALOSE WATER XANTHAN GUM XYLITOL Colorless
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 Pedia-Lax Docusate sodium Liquid Stool Softener 4 fl oz (118 mL) Pedia-Lax Docusate sodium Liquid Stool Softener 4 fl oz (118 mL)
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
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 using any laxative if your child has a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week If constipation continues after 1 week of use, contact your child's 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 (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information each 15 mL contains: sodium 13 mg the top of the bottle is sealed with foil for your safety. Do not use if foil imprinted "sealed for your protection" is broken or missing. gluten free
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-255-6960 or www.pedia-lax.com
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 using this product and consult a doctor if your child has rectal bleeding no bowel movement within 72 hours of using this product These symptoms may be signs of a serious condition.
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 Drug I nteraction P recaution: D o not give this product to your child if your child is presently taking mineral oil , unless directed by a doctor. Ask a doctor before using any laxative if your child has a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week If constipation continues after 1 week of use, contact your child's doctor Stop using this product and consult a doctor if your child has rectal bleeding no bowel movement within 72 hours of using this product These symptoms may be signs of a serious condition. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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