gc 451al 434

gc 451al 434
SPL v1
SPL
SPL Set ID 25c822ee-f23a-365e-e063-6394a90a06ee
Route
oral
Published
Effective Date 2013-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sennosides (8.6 mg)
Inactive Ingredients
cellulose, microcrystalline croscarmellose sodium dibasic calcium phosphate dihydrate magnesium stearate silicon dioxide

Identifiers & Packaging

Pill Appearance
Imprint: GC;434 Shape: round Color: brown Size: 8 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-07-01

Purpose

Laxative

Description

Sennosides 8.6 mg


Medication Information

Warnings

Do not use for more than one week unless directed by a doctor.

Ask a doctor before use if you have

• stomach pain, nausea or vomiting

• noticed a change in bowel habits that lasts over two 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 may indicate a serious condition.

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

Active Ingredient

Sennosides 8.6 mg

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

Laxative

Directions

• do not exceed 8 tablets in 24 hours

Age

Starting Dose

Maximum Dose

adults and children 12 years of age and older

2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor

4 tablets in the morning and 4 tablets at bedtime

children under 12 years

ask a doctor





Other Information
  • each tablet contains: calcium 40 mg
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
  • store at 20°C-25°C (68°F-77°F)
Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica

Description

Sennosides 8.6 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Package Label


Structured Label Content

Warnings

Do not use for more than one week unless directed by a doctor.

Ask a doctor before use if you have

• stomach pain, nausea or vomiting

• noticed a change in bowel habits that lasts over two 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 may indicate a serious condition.

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

Active Ingredient (Active ingredient (in each tablet))

Sennosides 8.6 mg

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

Laxative

Directions

• do not exceed 8 tablets in 24 hours

Age

Starting Dose

Maximum Dose

adults and children 12 years of age and older

2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor

4 tablets in the morning and 4 tablets at bedtime

children under 12 years

ask a doctor





Other Information (Other information)
  • each tablet contains: calcium 40 mg
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
  • store at 20°C-25°C (68°F-77°F)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica

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.

Package Label


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)