1122w-major

1122w-major
SPL v4
SPL
SPL Set ID 4a9e1cbe-ffe4-462f-a86d-078a357dcf49
Route
ORAL
Published
Effective Date 2025-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Hypromellose, Unspecified Magnesium Stearate Maltodextrin Microcrystalline Cellulose Light Mineral Oil Polyethylene Glycol 400 Talc

Identifiers & Packaging

Pill Appearance
Imprint: W2 Shape: round Color: brown Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-17

Description

Active ingredient (in each tablet) Sennosides 8.6 mg


Medication Information

Description

Active ingredient (in each tablet) Sennosides 8.6 mg

.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268



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

Overbagged with 10 tablets per bag, NDC 55154-2347-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Rev. 05.22

M-29

Re-order No. 701313

R51255

Distributed By:

Cardinal Health

Dublin, OH 43017

L58521081223

Uses

 relieves occasional constipation (irregularity)

 generally produces a bowel movement in 6-12 hours

Section 55105-1

Purpose

Laxative

Warnings

.

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

Do Not Use

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

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Other Information

each tablet contains: calcium 20 mg.

 store in a dry place at 15° – 30°C (59° – 86°F).

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, talc.

Questions Or Comments?

1-800-616-2471

Principal Display Panel

NDC 55154-2347-0

SENNA-LAX 8.6 mg

Sennosides Laxative

10 TABLETS

Stop Use and Ask A Doctor If

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

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


Structured Label Content

.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268



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

Overbagged with 10 tablets per bag, NDC 55154-2347-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Rev. 05.22

M-29

Re-order No. 701313

R51255

Distributed By:

Cardinal Health

Dublin, OH 43017

L58521081223

Uses

 relieves occasional constipation (irregularity)

 generally produces a bowel movement in 6-12 hours

Section 55105-1 (55105-1)

Purpose

Laxative

Warnings

.

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

Do Not Use (Do not use)

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

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Other Information (Other information)

each tablet contains: calcium 20 mg.

 store in a dry place at 15° – 30°C (59° – 86°F).

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, talc.

Questions Or Comments? (Questions or comments?)

1-800-616-2471

Principal Display Panel

NDC 55154-2347-0

SENNA-LAX 8.6 mg

Sennosides Laxative

10 TABLETS

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

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

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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (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


Advanced Ingredient Data


Raw Label Data

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