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

Warnings

.

Uses

 relieves occasional constipation (irregularity)

 generally produces a bowel movement in 6-12 hours

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

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.

Description

Active ingredient (in each tablet) Sennosides 8.6 mg

Principal Display Panel

NDC 55154-2347-0

SENNA-LAX 8.6 mg

Sennosides Laxative

10 TABLETS

.

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

Section 55105-1

Purpose

Laxative

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

Questions Or Comments?

1-800-616-2471

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

Warnings

.

Uses

 relieves occasional constipation (irregularity)

 generally produces a bowel movement in 6-12 hours

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

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.

Principal Display Panel

NDC 55154-2347-0

SENNA-LAX 8.6 mg

Sennosides Laxative

10 TABLETS

.

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

Section 55105-1 (55105-1)

Purpose

Laxative

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

Questions Or Comments? (Questions or comments?)

1-800-616-2471

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

All Sections (JSON)