f767e415-39d8-4c19-94a2-e9e07deaf0b4

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

Purpose

Laxative

Description

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


Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Drug Facts



Active ingredient (in each tablet)

Sennosides 8.6 mg

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.

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

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Drug Facts



Active ingredient (in each tablet)

Sennosides 8.6 mg

Indications and Usage (34067-9)

Uses

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

Laxative

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

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.

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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