371 - Senna Laxative

371 - Senna Laxative
SPL v1
SPL
SPL Set ID 9393032e-4343-4ac5-8e91-36013e5ca089
Route
ORAL
Published
Effective Date 2024-06-18
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 Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AZ217 Shape: round Color: brown Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-18

Description

Sennosides 8.6mg

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Sennosides 8.6mg

Use(s)
  • 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
Do Not Use

laxative products for longer than one week unless directed by a doctor

Other Information
  • each tablet contains: calcium 50mg
  • store at 20°C-25°C (68°F-77°F); excursions permitted between 15°-30°C (59°-86°F)
  • do not use if safety seal under cap is broken or missing
Questions/comments

Call 1-888-952-0050 Monday - Friday 9AM -5PM EST,

Active Ingredient(s)

Sennosides 8.6mg

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide

Principal Display Panel
Senna Laxative
Ask A Doctor Before Use If
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks 
Stop Use and Ask A Doctor If

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children

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


Structured Label Content

Use(s)
  • 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 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
Do Not Use (Do not use)

laxative products for longer than one week unless directed by a doctor

Other Information (Other information)
  • each tablet contains: calcium 50mg
  • store at 20°C-25°C (68°F-77°F); excursions permitted between 15°-30°C (59°-86°F)
  • do not use if safety seal under cap is broken or missing
Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday - Friday 9AM -5PM EST,

Active Ingredient(s) (Active ingredient(s))

Sennosides 8.6mg

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide

Principal Display Panel
Senna Laxative
Ask A Doctor Before Use If (Ask a doctor before use if)
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks 
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 could be signs of a serious condition.

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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