Senna Syrup
FDA Label NDC 68094-049

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Precision Dose, Inc. for the product Senna (NDC 68094-049). 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 other, active ingredient (in each teaspoonful), purpose, uses, otc - ask doctor, otc - do not use, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Senna Syrup
Natural Chocolate Flavor
8.8 mg/5 mL

For Hospital Use Only

Drug Facts

Alcohol Free, Gluten Free, Natural Vegetable Laxative

Manufactured for:
Akron Pharma Inc.
Fairfield, NJ 07004

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]

LI1378 Rev. 09/21

Active Ingredient (In Each Teaspoonful)

Sennosides 8.8 mg

Purpose

Laxative

Uses

relieves occasional constipation (irregularity), generally produces bowel movement in 6-12 hours

Otc - Ask Doctor

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

Otc - Do Not Use

Do not use laxative products for longer than 1 week unless directed by a doctor

Otc - Ask Doctor/Pharmacist

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

Otc - Stop Use

Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after use of laxative.

These may indicate a serious condition.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take preferably at bedtime or as directed by a doctor. Shake Well Before Using.

agestarting dosemaximum dosage
Adults and children 12 years and older2-3 teaspoons once a day3 teaspoons twice a day
Children 6 years to under 12 years1-1½ teaspoons once a day1½ teaspoons twice a day
Children 2 years to under 6 years½ - ¾ teaspoon once a day¾ teaspoon twice a day
Children under 2 yearsask a doctorask a doctor

Other Information

  • avoid excessive heat
  • store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

flavor chocolate, methylparaben, propylene glycol, propylparaben, purified water and sucrose.

Questions Or Comments?

To Report Adverse Drug Events Call (815) 397-9228

How Supplied

NDC 68094-049-62
5 mL per unit dose cup
Thirty (30) cups per shipper

Principal Display Panel - 5 Ml Cup Label

NDC 68094-049-59
PrecisionDose™

Senna Syrup
8.8 mg/5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

Principal Display Panel (5 mL Cup Label)

Principal Display Panel (5 mL Cup Label)

* Please review the disclaimer below.