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| Product NDC Code | 0132-0106 | ||||
|---|---|---|---|---|---|
| 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 tablespoon) Docusate sodium 50 mg, Stool softener
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 Use dosage chart for proper dosing. Doses may be taken as a single daily dose or in divided doses. Doses can be given in a glass of juice to prevent throat irritation and to help mask the naturally tart flavor of the active ingredient. Age Starting Dose Maximum dose per day (24 hours) children 2 to 12 years 1 - 3 tablespoons 3 tablespoons children under 2 years ask a doctor
| Age | Starting Dose | |
| children 2 to 12 years | 1 - 3 tablespoons | 3 tablespoons |
| 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, FD and C red 3, 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 the prevention of dry, hard stools for relief of occasional constipation this product generally produces bowel movement in 12-72 hours
Purpose
Information about the drug product’s indications for use.Other information each tablespoon contains: sodium 13 mg CHILD RESISTANT CAP 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
Spl product data elements
Usually a list of ingredients in a drug product.Pedia-Lax Docusate Sodium DOCUSATE SODIUM DOCUSATE EDETATE DISODIUM XYLITOL XANTHAN GUM WATER SUCRALOSE SORBITOL SODIUM CITRATE POVIDONE METHYLPARABEN PROPYLENE GLYCOL ANHYDROUS CITRIC ACID FD&C RED NO. 3 POLYETHYLENE GLYCOL 4500 PROPYLPARABEN
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.Pedia-Lax Liquid Stool Softener Carton
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? 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 horus 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 interaction precaution: do 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 abdominal pain, nausea or vomiting 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, contac your child's 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