Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 94a9c24a-07c3-4535-b810-b7abc9fc5ad5
Route
ORAL
Published
Effective Date 2019-12-11
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
Shape: round Color: brown Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-07-01

Description

Sennosides 8.6mg

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Sennosides 8.6mg

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
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 ½ 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

Active Ingredient

Sennosides 8.6mg

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
Inactive Ingredients

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

Principal Display Panel
Senna Lax
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.

Keep Out of Reach of Childen.

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

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
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 ½ 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

Active Ingredient (Active ingredient)

Sennosides 8.6mg

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
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel
Senna Lax
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.

Keep Out of Reach of Childen. (Keep out of reach of childen.)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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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