SPL v6
SPL
SPL Set ID f767e415-39d8-4c19-94a2-e9e07deaf0b4
Route
ORAL
Published
Effective Date 2025-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg)
Inactive Ingredients
Microcrystalline Cellulose Magnesium Stearate Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: RP117 Shape: round Color: brown Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-09

Description

Drug Facts Active ingredient (in each tablet) Sennosides 8.6 mg

Purpose

Laxative


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6–12 hours
Purpose

Laxative

Dosage and Administration

Directions

  • take preferably at bedtime or as directed by a doctor

age

starting dosage

maximum dosage

adults and children

12 years of age and over

2 tablets once a day

4 tablets twice a day

children 6 to under 12 years

1 tablet once a day

2 tablets twice a day

children 2 to under 6 years

1/2 tablet once a day

1 tablet twice a day

children under 2 years

ask a doctor

ask a doctor

Description

Drug Facts Active ingredient (in each tablet) Sennosides 8.6 mg

Section 42229-5

Other Information

  • store at room temperature
Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-22-1222.

Section 50566-9

Stop use and ask a doctor if you haverectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Section 50568-5

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks
Section 50570-1

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
Section 51727-6

Inactive ingredients

microcrystalline cellulose, magnesium stearate, starch

Section 51945-4

*Compare to the active ingredient of Senokot®

exchange√select

Senna-Lax

Vegetable Laxative From Senna Concentrate For Gentle Relief of Constipation

100 Tablets

*Compare to the active ingredient of Senokot®

NDC 55301-107-00

exchange√select

Senna-Lax

Vegetable Laxative From Senna Concentrate For Gentle Relief of Constipation

100 Tablets

Section 53414-9

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

Section 55106-9

Drug Facts



Active ingredient (in each tablet)

Sennosides 8.6 mg

Questions Or Comments?

1-866-467-2748

Tamper Evident: Do Not Use If Printed Seal Under Cap Is Broken Or Missing

IMPORTANT: Keep this carton for future reference on full labeling.

*This product is not manufactured or distributed by Avrio Health L.P., owner of the registered trademark Senokot®

SATISFACTION GUARANTEED OR YOUR MONEY BACK”



Manufactured For Your Military Exchanges By: Raritan Pharmaceuticals Inc., 8 Joanna Court, East Brunswick, NJ 08816


Structured Label Content

Indications and Usage (34067-9)

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6–12 hours
Dosage and Administration (34068-7)

Directions

  • take preferably at bedtime or as directed by a doctor

age

starting dosage

maximum dosage

adults and children

12 years of age and over

2 tablets once a day

4 tablets twice a day

children 6 to under 12 years

1 tablet once a day

2 tablets twice a day

children 2 to under 6 years

1/2 tablet once a day

1 tablet twice a day

children under 2 years

ask a doctor

ask a doctor

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Other Information

  • store at room temperature
Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-22-1222.

Section 50566-9 (50566-9)

Stop use and ask a doctor if you haverectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Section 50568-5 (50568-5)

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks
Section 50570-1 (50570-1)

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
Section 51727-6 (51727-6)

Inactive ingredients

microcrystalline cellulose, magnesium stearate, starch

Section 51945-4 (51945-4)

*Compare to the active ingredient of Senokot®

exchange√select

Senna-Lax

Vegetable Laxative From Senna Concentrate For Gentle Relief of Constipation

100 Tablets

*Compare to the active ingredient of Senokot®

NDC 55301-107-00

exchange√select

Senna-Lax

Vegetable Laxative From Senna Concentrate For Gentle Relief of Constipation

100 Tablets

Section 53414-9 (53414-9)

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

Section 55106-9 (55106-9)

Drug Facts



Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Tamper Evident: Do Not Use If Printed Seal Under Cap Is Broken Or Missing (TAMPER EVIDENT: Do not use if printed seal under cap is broken or missing)

IMPORTANT: Keep this carton for future reference on full labeling.

*This product is not manufactured or distributed by Avrio Health L.P., owner of the registered trademark Senokot®

SATISFACTION GUARANTEED OR YOUR MONEY BACK”



Manufactured For Your Military Exchanges By: Raritan Pharmaceuticals Inc., 8 Joanna Court, East Brunswick, NJ 08816


Advanced Ingredient Data


Raw Label Data

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