chocolate flavored senna sennosides, 8.6 mg chewable laxative

chocolate flavored senna sennosides, 8.6 mg chewable laxative
SPL v3
SPL
SPL Set ID 5850b0ce-7891-4570-b417-aead1efd4e9b
Route
oral
Published
Effective Date 2017-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sennosides (8.6 mg)
Inactive Ingredients
cocoa crospovidone (15 mpa.s at 5%) dextrose, unspecified form magnesium stearate maltodextrin starch, corn sucralose

Identifiers & Packaging

Pill Appearance
Imprint: R126 Shape: round Color: brown Size: 19 mm Score: 1
Marketing Status
otc monograph not final active Since 2015-08-21

Purpose

Laxative

Description

Drug Facts Active ingredient (in each tablet) Sennosides 8.6 mg


Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Indications and Usage

Uses

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

Laxative

Dosage and Administration

Directions

  • chew tablet 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

once a day

children under

2 years

ask a doctor

ask a doctor

Description

Drug Facts Active ingredient (in each tablet) Sennosides 8.6 mg

Section 42229-5

Other Information

  • each tablet contains: calcium 10 mg
  • do not use if printed seal under cap is torn or missing
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

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 50568-5

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 50570-1

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
Section 51727-6

Inactive ingredients

cocoa powder, crospovidone, dextrose, flavors, magnesium stearate, maltodextrin, starch, sucralose

Section 51945-4
Section 53414-9

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


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Indications and Usage (34067-9)

Uses

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

Laxative

Dosage and Administration (34068-7)

Directions

  • chew tablet 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

once a day

children under

2 years

ask a doctor

ask a doctor

Section 42229-5 (42229-5)

Other Information

  • each tablet contains: calcium 10 mg
  • do not use if printed seal under cap is torn or missing
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

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 50568-5 (50568-5)

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 50570-1 (50570-1)

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
Section 51727-6 (51727-6)

Inactive ingredients

cocoa powder, crospovidone, dextrose, flavors, magnesium stearate, maltodextrin, starch, sucralose

Section 51945-4 (51945-4)
Section 53414-9 (53414-9)

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


Advanced Ingredient Data


Raw Label Data

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