Careall Sennosides Tablet
FDA Label NDC 51824-058

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Careall Sennosides (NDC 51824-058). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Sennosides

Purpose

Laxative

Keep Out Of Reach Of Children

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Uses

For relief of occasional constipation and irregularity.

This product produces a bowel movement in 6 to 12 hours.

Warnings

Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Ask a doctor before use if you have a sudden change in bowel habits that persists over a period of 2 weeks.

Ask a doctor or pharmacist before use if you are taking a prescription drug.  Laxatives may affect how other drugs work.  Take this product 2 or more hours before or after other drugs.

When using this product do not use for longer than 1 week unless directed by a doctor

Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use of a laxative.  These could be signs of a serious condition.

If Pregnant or breast-feeding ask a health professional before use.

Directions

Take preferably at bedtime or as directed by a doctor.  If you do not have comfortable bowel movement by the second day, increase dose by one tablet (do not exceed the maximum dosage) or decrease dose until you are comfortable.

Adults and children over 12 years: 2 tablets once a day.  Maximum of 4 tablets twice a day.

Children 6 to under 12 years: 1 tablet once a day.  Maximum of 2 tablets twice a day.

Children 2 to under 6 years: 1/2 tablet once a day.  Maximum of 1 tablet twice a day.

Children under 2: consult a doctor


Inactive Ingredients

croscarmellose sodium, dibasic dicalcium phosphate, lactose, magnesium stearate, microcrystalline cellulose, and silicon dioxide.

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