Senna 8.6mg Tabs

Senna 8.6mg Tabs
SPL v2
SPL
SPL Set ID 18d7bd07-f3a3-4140-bfb6-4e734f9b6649
Route
ORAL
Published
Effective Date 2017-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides A And B (8.6 mg)
Inactive Ingredients
Croscarmellose Sodium Calcium Phosphate, Dibasic, Dihydrate Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Mineral Oil

Identifiers & Packaging

Pill Appearance
Imprint: TCL080 Shape: round Color: brown Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-02-01

Description

Sennosides 8.6 mg

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Sennosides 8.6 mg

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
 a ge

 starting dosage

 maximum dosage

 adults and children 12 years of age or older

 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
Other Information
  • each tablet contains: calcium 25 mg, sodium 2mg (very low sodium)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, , magnesium stearate, microcrystalline cellulose, mineral oil

Questions Or Comments?

call 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday

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

Principal Display Panel

NDC: 17714-122-01

Senna 8.6mg

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 right away.

Active Ingredient (in Each Tablet)

Sennosides 8.6 mg

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

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

Laxative

Directions
  • take preferably at bedtime or as directed by a doctor
 a ge

 starting dosage

 maximum dosage

 adults and children 12 years of age or older

 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
Other Information (Other information)
  • each tablet contains: calcium 25 mg, sodium 2mg (very low sodium)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, , magnesium stearate, microcrystalline cellulose, mineral oil

Questions Or Comments? (Questions or comments?)

call 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday

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

Principal Display Panel

NDC: 17714-122-01

Senna 8.6mg

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 right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Sennosides 8.6 mg

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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