ac8c3b11-8068-59e6-e053-2a95a90a3256

SPL v1
SPL
SPL Set ID ac8c3b11-8068-59e6-e053-2a95a90a3256
Route
oral
Published
Effective Date 2020-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sennosides (8.6 mg)
Inactive Ingredients
sodium lauryl sulfate microcrystalline cellulose silicon dioxide stearic acid d7 paraffin dibasic calcium phosphate dihydrate hypromelloses magnesium stearate maltodextrin croscarmellose sodium

Identifiers & Packaging

Pill Appearance
Imprint: none Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
otc monograph not final active Since 2020-08-03

Purpose

Laxative

Description

Sennosides 8.6 mg


Medication Information

Purpose

Laxative

Directions

Take preferably at bedtime or as directed by a doctor.

Other Information

store at 20-25°C (68-77°F) excursions permitted between15°-30°C (59°-86°F)

each tablet contains: Calcium 25 mg & sodium 3 mg

Inactive Ingredients

Colloidal silicon dioxide,croscarmellose sodium, Dicalcium phosphate, Hypromellose, liquid paraffin, magnesium stearate, microcrystalline cellulose, Maltodextrin, Purified water, Sodium lauryl sulphate, Stearic Acid.

Description

Sennosides 8.6 mg

Principal Display Panel

Uses:

relieves occasional constipation (irregularity).

generally causes bowel movement within 6 to 12 hours.

Pregnancy

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

Warnings:

Do not use -

Laxative products for longer than 1 week, unless directed by a doctor.

If you have ever had an allergic reaction to this product or any of its ingredients.

Ask Doctor:

Ask a doctor before use if you have - Stomach pain, nausea, vomiting, a sudden change in bowel movements that persists over 2 weeks

Active Ingredient

Sennosides 8.6 mg

Ask Doctor/pharmacist:

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.

Questions Or Comments?

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222), Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Structured Label Content

Purpose

Laxative

Directions (DIRECTIONS)

Take preferably at bedtime or as directed by a doctor.

Other Information (OTHER INFORMATION)

store at 20-25°C (68-77°F) excursions permitted between15°-30°C (59°-86°F)

each tablet contains: Calcium 25 mg & sodium 3 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

Colloidal silicon dioxide,croscarmellose sodium, Dicalcium phosphate, Hypromellose, liquid paraffin, magnesium stearate, microcrystalline cellulose, Maltodextrin, Purified water, Sodium lauryl sulphate, Stearic Acid.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Uses:

relieves occasional constipation (irregularity).

generally causes bowel movement within 6 to 12 hours.

Pregnancy (PREGNANCY)

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

Warnings:

Do not use -

Laxative products for longer than 1 week, unless directed by a doctor.

If you have ever had an allergic reaction to this product or any of its ingredients.

Ask Doctor:

Ask a doctor before use if you have - Stomach pain, nausea, vomiting, a sudden change in bowel movements that persists over 2 weeks

Active Ingredient

Sennosides 8.6 mg

Ask Doctor/pharmacist: (ASK DOCTOR/PHARMACIST:)

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.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222), Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Advanced Ingredient Data


Raw Label Data

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