Senna

Senna
SPL v4
SPL
SPL Set ID cfb6bf89-c77e-4372-9bc9-44d6a659c955
Route
ORAL
Published
Effective Date 2025-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-06

Description

Sennosides  8.8 mg                                                                                                      Laxative

Purpose

Sennosides  8.8 mg                                                                                                      Laxative


Medication Information

Purpose

Sennosides  8.8 mg                                                                                                      Laxative

Description

Sennosides  8.8 mg                                                                                                      Laxative

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

Do not use

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

Directions

  • shake well before using               • Do not exceed recommended dose

 Age  Starting Dose  Maximum Dose
 adults and children 12 years

and older
 2 to 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


Distributed By:

R10/24

MAJOR® PHARMACEUTICALS

Indianapolis, IN  46268

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 0904-7528-41: 5 mL unit dose cup, in a tray of ten cups.

NDC 0904-7528-94: Case contains 40 unit dose cups of 5 mL (0904-7528-41) packaged in 4 trays of 10 unit dose cups each.

Inactive Ingredients:

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

Questions Or Comments?

Call 1-800-845-8210.

Principal Display Panel

Major® 

NDC  09045-7528-41

Senna Syrup

8.8 mg Sennosides/5 mL

Stop Use and Ask A Doctor If

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

If Pregnant Or Breastfeeding,

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.

Ask A Doctor Or Pharmacist Before Use If You Have

      • stomach pain     • nausea     • vomiting

      • noticed a change in bowel movement that continues over a period of 2 weeks

Active Ingredient (per Teaspoonful 5 Ml)                                                                          Purpose

Sennosides  8.8 mg                                                                                                      Laxative


Structured Label Content

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

Do not use

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

Directions

  • shake well before using               • Do not exceed recommended dose

 Age  Starting Dose  Maximum Dose
 adults and children 12 years

and older
 2 to 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


Distributed By: (Distributed by:)

R10/24

MAJOR® PHARMACEUTICALS

Indianapolis, IN  46268

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 0904-7528-41: 5 mL unit dose cup, in a tray of ten cups.

NDC 0904-7528-94: Case contains 40 unit dose cups of 5 mL (0904-7528-41) packaged in 4 trays of 10 unit dose cups each.

Inactive Ingredients: (Inactive ingredients:)

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

Questions Or Comments? (Questions or comments?)

Call 1-800-845-8210.

Principal Display Panel

Major® 

NDC  09045-7528-41

Senna Syrup

8.8 mg Sennosides/5 mL

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

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.

Ask A Doctor Or Pharmacist Before Use If You Have (Ask a doctor or pharmacist before use if you have)

      • stomach pain     • nausea     • vomiting

      • noticed a change in bowel movement that continues over a period of 2 weeks

Active Ingredient (per Teaspoonful 5 Ml)                                                                          Purpose (Active ingredient (per teaspoonful - 5 mL)                                                                          Purpose)

Sennosides  8.8 mg                                                                                                      Laxative


Advanced Ingredient Data


Raw Label Data

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