drug facts

drug facts
SPL v3
SPL
SPL Set ID 5bbcb8c2-16e9-4b98-b75e-4f72a2480564
Route
oral
Published
Effective Date 2006-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sennosides (8.6 mg)
Inactive Ingredients
calcium carbonate croscarmellose sodium sodium sulfate hypromelloses magnesium stearate maltodextrin cellulose, microcrystalline propylene glycol silicon dioxide stearic acid triacetin

Identifiers & Packaging

Pill Appearance
Imprint: GPI;W2 Shape: round Color: brown Size: 9 mm Score: 2
Marketing Status
otc monograph not final active Since 2006-03-27

Purpose

Laxative

Description

Sennosides 8.6 mg


Medication Information

Warnings


Active Ingredient

Sennosides 8.6 mg

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
age starting dosage maximum dosage
adults and children 12 years of age and older

2 tablets once a day

4 tablets twice a day

children 6 to under 12 years of age

1 tablet once a day

2 tablets twice a day

children 2 to under 6 years of age

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 at room temperature
  • Do not use if imprinted seal under cap is broken or missing
Inactive Ingredients

Calcium carbonate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium sulfate, stearic acid, triacetin.

Description

Sennosides 8.6 mg

Questions?

If you have any questions or comments,or to report an adverse event, please contact (800) 795-9775.

Do Not Use
  • laxative products for longer than 1 week unless directed by a doctor

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.

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

Plus Pharma Senna Standardized Senna Concentrate 8.6 Mg Sennosides Each (sennosides) Tablet, Film Coated

Structured Label Content

Warnings


Active Ingredient (Active ingredient (in each tablet))

Sennosides 8.6 mg

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
age starting dosage maximum dosage
adults and children 12 years of age and older

2 tablets once a day

4 tablets twice a day

children 6 to under 12 years of age

1 tablet once a day

2 tablets twice a day

children 2 to under 6 years of age

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 at room temperature
  • Do not use if imprinted seal under cap is broken or missing
Inactive Ingredients (Inactive ingredients)

Calcium carbonate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium sulfate, stearic acid, triacetin.

Questions?

If you have any questions or comments,or to report an adverse event, please contact (800) 795-9775.

Do Not Use (Do not use)
  • laxative products for longer than 1 week unless directed by a doctor

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.

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

Plus Pharma Senna Standardized Senna Concentrate 8.6 Mg Sennosides Each (sennosides) Tablet, Film Coated (PLUS PHARMA SENNA STANDARDIZED SENNA CONCENTRATE 8.6 MG SENNOSIDES EACH (SENNOSIDES) TABLET, FILM COATED)

Advanced Ingredient Data


Raw Label Data

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