Senna

Senna
SPL v7
SPL
SPL Set ID 7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed
Route
ORAL
Published
Effective Date 2025-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.8 mg)
Inactive Ingredients
Citric Acid Acetate Glycerin Methylparaben Potassium Sorbate Propylparaben Water Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-22

Description

(per teaspoonful - 5 mL) Sennosides - 8.8 mg

Purpose

Laxative

Dosage and Administration

shake well before use Do not exceed recommended dose Age Starting Dose  Maximum dosage  Adults and children 12 years and older  2-3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor 3 teaspoons in the morning and 3 teaspoons at bedtime Under 12 years of age  ask a doctor  ask a doctor Other information store at room temperature 20° to 25°C (68° to 77°F). a brown, natural flavored syrup supplied in the following oral dosage form: NDC 0121-4967-05: 5 mL unit dose cup, in a tray of ten cups. NDC 0121-4967-40: Case contains 40 unit dose cups of 5 mL (0121-4967-05) packaged in 4 trays of 10 unit dose cups each.


Medication Information

Purpose

Laxative

Dosage and Administration
  • shake well before use
  • Do not exceed recommended dose
Age Starting Dose  Maximum dosage
 Adults and children 12 years and older  2-3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor 3 teaspoons in the morning and 3 teaspoons at bedtime
Under 12 years of age  ask a doctor  ask a doctor

Other information

  • store at room temperature 20° to 25°C (68° to 77°F).
  • a brown, natural flavored syrup supplied in the following oral dosage form:

NDC 0121-4967-05: 5 mL unit dose cup, in a tray of ten cups.

NDC 0121-4967-40: Case contains 40 unit dose cups of 5 mL (0121-4967-05) packaged in 4 trays of 10 unit dose cups each.

Description

(per teaspoonful - 5 mL) Sennosides - 8.8 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally causes bowel movment in 6 to 12 hours
Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor

Ask a doctor or pharmacist before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden changed in bowel movement that continues over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or failure to have a bowel movemebt after use of laxative. They may indicate a serious condition.

Distributed By:

Pharmaceutical Associates, Inc.

Greenville, SC 29605

Active Ingredient

(per teaspoonful - 5 mL)

Sennosides - 8.8 mg

Inactive Ingredients:

 citric acid, glycerin, methylparaben, potassium sorbate, propylparaben, purified water, and sucrose.

Questions Or Comments?

 1-800-845-8210

Principal Display Panel

Delivers 5 mL

NDC 0121-4967-05

Senna Syrup

8.8 mg Sennosides/5 mL

Natural Vegetable Laxative

Package Not Child-Resistant

Pharmacutical Associates, Inc.

Greenville, SC 29605

SEE DRUG FACTS

If Pregnant Or Breast Feeding

 ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally causes bowel movment in 6 to 12 hours
Purpose

Laxative

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor

Ask a doctor or pharmacist before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden changed in bowel movement that continues over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or failure to have a bowel movemebt after use of laxative. They may indicate a serious condition.

Distributed By:

Pharmaceutical Associates, Inc.

Greenville, SC 29605

Active Ingredient (ACTIVE INGREDIENT)

(per teaspoonful - 5 mL)

Sennosides - 8.8 mg

Inactive Ingredients: (Inactive ingredients:)

 citric acid, glycerin, methylparaben, potassium sorbate, propylparaben, purified water, and sucrose.

Questions Or Comments? (Questions or comments?)

 1-800-845-8210

Principal Display Panel

Delivers 5 mL

NDC 0121-4967-05

Senna Syrup

8.8 mg Sennosides/5 mL

Natural Vegetable Laxative

Package Not Child-Resistant

Pharmacutical Associates, Inc.

Greenville, SC 29605

SEE DRUG FACTS

Dosage and Administration (DOSAGE AND ADMINISTRATION)
  • shake well before use
  • Do not exceed recommended dose
Age Starting Dose  Maximum dosage
 Adults and children 12 years and older  2-3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor 3 teaspoons in the morning and 3 teaspoons at bedtime
Under 12 years of age  ask a doctor  ask a doctor

Other information

  • store at room temperature 20° to 25°C (68° to 77°F).
  • a brown, natural flavored syrup supplied in the following oral dosage form:

NDC 0121-4967-05: 5 mL unit dose cup, in a tray of ten cups.

NDC 0121-4967-40: Case contains 40 unit dose cups of 5 mL (0121-4967-05) packaged in 4 trays of 10 unit dose cups each.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

 ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.


Advanced Ingredient Data


Raw Label Data

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