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Product NDC Code | 17856-1127 | ||||||||||
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Drug Name | Onelax senna |
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Type | Brand | ||||||||||
Active Ingredients |
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Route | ORAL | ||||||||||
Dosage Form | SYRUP | ||||||||||
RxCUI drug identifier | 702311 | ||||||||||
Application Number | M007 | ||||||||||
Labeler Name | ATLANTIC BIOLOGICALS CORP. | ||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Active ingredient (in each teaspoonful) Purpose Sennosides 8.8 mg …………………………................Laxative
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 starting dose maximum dosage Adults and children 12 yeart and older 2-3 teaspoons once a day 3 teaspoons twice a day Children 6 years to under 12 yeart 1 - 1 1/2 teaspoons once a day 1 1/2 teaspoons twice a day Children 2 years to under 6 yeart l/2 - 3/4 teaspoon once a day 3/4 teaspoon twice a day Children under 2 years ask a doctor ask a doctor
Adults and children 12 yeart and older | 2-3 teaspoons once a day | 3 teaspoons twice a day |
Children 6 years to under 12 yeart | 1 - 1 1/2 teaspoons once a day | 11/2 teaspoons twice a day |
Children 2 years to under 6 yeart | l/2 - 3/4 teaspoon once a day | 3/4 teaspoon twice a day |
Children under 2 years | ask a doctor | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients flavor choclate, mythylparaben, propylene glycol, propylparaben, purified water and sucrose
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.Directions take preferably at bedtime or as directed by a doctor. Shake Well Before Using.
Purpose
Information about the drug product’s indications for use.Uses relieves occasional constipation (irregularity), generally causes bowel movement in 6 to 12 hours
Spl product data elements
Usually a list of ingredients in a drug product.OneLAX SENNA SENNA SENNOSIDES A AND B SENNOSIDES A AND B METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SUCROSE
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 1 LABEL 2 LABEL 3
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 or pharmacist before use if you are taking any other drug. Take this product two more hours before or after other drugs. Laxatives may affect how other drugs work.
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.
KEEP OUT OF REACH OF CHILDREN SECTION In case of accidental overdose, get medical help or contact a Poison Control Center immediately Questions? To Report Adverse Drug Event Call 1(877) 225-6999 DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP. MIAMI, FL 33179
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 bowel movement after use of laxative. This may indicate a serious condition.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Avoid accessive heat. Store at room temperature 15°-30°C (59°-86°F)
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 ask a doctor before use if you have • stomach pain • nausea • vomiting • noticed a sudden change in bowel movements that continues over a period of 2 weeks Do not use laxative products for longer than 1 week unless directed by a doctor Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two more hours before or after other drugs. Laxatives may affect how other drugs work. Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after use of laxative. This may indicate a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center 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