ce0938d4-efd1-4efb-8e51-037f7040080e

SPL v2
SPL
SPL Set ID ce0938d4-efd1-4efb-8e51-037f7040080e
Route
oral
Published
Effective Date 2024-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sennosides (8.6 mg)
Inactive Ingredients
sodium lauryl sulfate microcrystalline cellulose silicon dioxide stearic acid d7 paraffin dibasic calcium phosphate dihydrate hypromelloses magnesium stearate maltodextrin croscarmellose sodium

Identifiers & Packaging

Pill Appearance
Imprint: none Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-10-03

Purpose

Laxative

Description

Sennosides 8.6 mg


Medication Information

Purpose

Laxative

Directions
  • Take preferably at bedtime or as directed by a doctor.

age

starting dosage

maximum dosage

adults & 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
  • store at 20-25°C (68-77°F) excursions permitted between15°-30°C (59°-86°F)
  • each tablet contains: Calcium 25 mg & sodium 3 mg
Inactive Ingredients

Colloidal silicon dioxide,croscarmellose sodium, Dicalcium phosphate, Hypromellose, liquid paraffin, magnesium stearate, microcrystalline cellulose, Maltodextrin, Purified water, Sodium lauryl sulphate, Stearic Acid.

Description

Sennosides 8.6 mg

Uses:
  • relieves occasional constipation (irregularity).
  • generally prodcues a bowel movement in 6-12 hours
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 51945-4

Section 53414-9

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

Warnings:

Do not use

  • Laxative products for longer than 1 week, unless directed by a doctor.
Active Ingredient

Sennosides 8.6 mg

Questions Or Comments?

Call + 1-732-994-2808 or email [email protected]

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. 


Structured Label Content

Purpose

Laxative

Directions (DIRECTIONS)
  • Take preferably at bedtime or as directed by a doctor.

age

starting dosage

maximum dosage

adults & 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)
  • store at 20-25°C (68-77°F) excursions permitted between15°-30°C (59°-86°F)
  • each tablet contains: Calcium 25 mg & sodium 3 mg
Inactive Ingredients (INACTIVE INGREDIENTS)

Colloidal silicon dioxide,croscarmellose sodium, Dicalcium phosphate, Hypromellose, liquid paraffin, magnesium stearate, microcrystalline cellulose, Maltodextrin, Purified water, Sodium lauryl sulphate, Stearic Acid.

Uses:
  • relieves occasional constipation (irregularity).
  • generally prodcues a bowel movement in 6-12 hours
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 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Warnings:

Do not use

  • Laxative products for longer than 1 week, unless directed by a doctor.
Active Ingredient

Sennosides 8.6 mg

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call + 1-732-994-2808 or email [email protected]

Keep Out of Reach of Children (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. 


Advanced Ingredient Data


Raw Label Data

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