hpc 451al 434

hpc 451al 434
SPL v3
SPL
SPL Set ID 1e003905-68d8-1aa5-e063-6394a90a5918
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
carnauba wax 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 completed Since 2024-08-01 Until 2026-10-31

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

• if taking the starting dosage,

take preferably at bedtime; or as directed by

a doctor. • If taking the maximum dosage,

take in the morning and at bedtime.

Age

Starting Dose

Maximum Dose

adults and children 12 years of age and older

2 tablets once a day 4 tablets

twice a day

children 6

to under 12

years
1 tablets once a day 2 tablets

twice a day
children 2

to under 6

years
1/2 tablets once a day 1 tablets

twice a day
children

to under 2

years
Ask a doctor Ask a doctor







Other Information
  • each tablet contains: calcium 40 mg
  • store at 20°C-25°C (68°F-77°F)
Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica. May also contain wax.

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

• if taking the starting dosage,

take preferably at bedtime; or as directed by

a doctor. • If taking the maximum dosage,

take in the morning and at bedtime.

Age

Starting Dose

Maximum Dose

adults and children 12 years of age and older

2 tablets once a day 4 tablets

twice a day

children 6

to under 12

years
1 tablets once a day 2 tablets

twice a day
children 2

to under 6

years
1/2 tablets once a day 1 tablets

twice a day
children

to under 2

years
Ask a doctor Ask a doctor







Other Information (Other information)
  • each tablet contains: calcium 40 mg
  • store at 20°C-25°C (68°F-77°F)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica. May also contain wax.

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)