1122w-major

1122w-major
SPL v2
SPL
SPL Set ID df3b431b-a1ad-91dd-e053-2995a90aa02f
Route
ORAL
Published
Effective Date 2022-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: W2 Shape: round Color: brown Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-17

Description

Active ingredient (in each tablet) Sennosides 8.6 mg


Medication Information

Description

Active ingredient (in each tablet) Sennosides 8.6 mg

Uses

 relieves occasional constipation (irregularity)

 generally produces a bowel movement in 6-12 hours

Section 34088-5

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

Section 42229-5

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®.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50569-3

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

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

Section 51727-6

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

Section 51945-4

Major

NDC 0904-7252-80

Compare to the active ingredient in Senokot® Tablets*

Senna Tablets

Sennosides

8.6 mg

Natural Vegetable Laxative Ingredient

1000 Tablets

Section 53414-9

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

Section 55105-1

Purpose

Laxative

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

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).

Questions Or Comments?

1-800-616-2471


Structured Label Content

Uses

 relieves occasional constipation (irregularity)

 generally produces a bowel movement in 6-12 hours

Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

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®.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

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)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Major

NDC 0904-7252-80

Compare to the active ingredient in Senokot® Tablets*

Senna Tablets

Sennosides

8.6 mg

Natural Vegetable Laxative Ingredient

1000 Tablets

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Laxative

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

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).

Questions Or Comments? (Questions or comments?)

1-800-616-2471


Advanced Ingredient Data


Raw Label Data

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