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| Product NDC Code | 71399-0039 | ||||
|---|---|---|---|---|---|
| Drug Name | Onelax |
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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 | Akron Pharma | ||||
| 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.Drug Facts Active ingredient (in each 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.Age Dose Adults and children over 12 years of age and over 1 to 6 teaspoons (5 mL - 30 mL) Children under 12 years of age Ask a doctor
| Age | Dose |
| Adults and children over 12 years of age and over | 1 to 6 teaspoons (5 mL - 30 mL) |
| Children under 12 years of age | Ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Anhydrous citric acid, D&C red#33, Flavor vanilla, Glycerin, Methyl Paraben, Propylene glycol, Propyl paraben, Poloxamer 407, Purified water, Sodium benzoate, Sodium citrate, Sorbitol solution, 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 relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Purpose
Information about the drug product’s indications for use.Purpose Stool Softner Laxative
Spl product data elements
Usually a list of ingredients in a drug product.OneLAX Docusate Sodium DOCUSATE SODIUM DOCUSATE ANHYDROUS CITRIC ACID D&C RED NO. 33 GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN POLOXAMER 407 WATER SODIUM BENZOATE SODIUM CITRATE SORBITOL SOLUTION 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.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 stomach pain, nausea or vomiting have sudden change in bowel habits that persists over a period of 2 weeks are presently taking mineral oil
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information wach teaspoonful (5 ml) contains: sodium 5 mg store at room temperature 15 o - 30 o C (59 o - 86 o F) protect from excessive heat Pharmacist-preserve and dispense in a tight, light resistant container with a child resistant cap as defined in the USP Temper -Evident: Do not use if foil over bottle opening is torn, broken, or missing
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? call toll-free 1-877-225-6999 Manufactured for: Akron Pharma, Inc. Fairfield, NJ 07004 www.akronpharma.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 use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of this product. These could be signs of a serious condition. a skin rash occurs you experience throat irritation
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.Directions shake well before using follow dosing directions below or use as directed by a physician do not exceed recommended dose must be given in a 6 oz to 8 oz glass of milk or fruiit juice to prevent throat irritation take maximum dose daily until first bowel movement, dosage should then be reduced according to indivisual response
Pregnancy or breast feeding
Pregnancy or Breast feedingif pregnant or breast-feeding, ask 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 for more than one week unless directed 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