Topcare Laxative - Sennosides 8.6mg

Topcare Laxative - Sennosides 8.6mg
SPL v5
SPL
SPL Set ID 979b09ce-4824-4f05-9f61-484a46a7c3cc
Route
ORAL
Published
Effective Date 2021-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg)
Inactive Ingredients
Silicon Dioxide Yellow Wax Povidone K30 Fd&c Red No. 40 Fd&c Yellow No. 6 Fd&c Blue No. 1 Gelatin Glycerin Mineral Oil Carboxymethylcellulose Sodium Sorbitol Solution Lecithin, Soybean Titanium Dioxide Water

Identifiers & Packaging

Pill Appearance
Imprint: 458 Shape: oval Color: brown Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-13

Description

Sennosides 8.6 mg

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Sennosides 8.6 mg

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  1/2 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 1 week unless directed by a doctor
Other Information
  • each tablet contains: calcium 1mg and sodium less than 1mg
  • store at 25 oC (77 o F); excursions permitted between 15 _30 oC (59 _86 oF)
Inactive Ingredients

aerosil, beeswax, FD&C Blue No. 1, FD&C Red No.40, FD&C Yellow No. 6, gelatin, glycerin,

light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethyl cellulose,

sorbitol solution, soya lecithin, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

TopCare health™

COMPARE TO SENOKOT® ACTIVE INGREDIENT*

Laxative

SENNOSIDES 8.6 mg • LAXATIVE

Gentle, Overnight Relief

60 SOFTGELS

actual size

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.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Softgel)

Sennosides 8.6 mg

Ask A Doctor Before Using 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  1/2 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 1 week unless directed by a doctor
Other Information (Other information)
  • each tablet contains: calcium 1mg and sodium less than 1mg
  • store at 25 oC (77 o F); excursions permitted between 15 _30 oC (59 _86 oF)
Inactive Ingredients

aerosil, beeswax, FD&C Blue No. 1, FD&C Red No.40, FD&C Yellow No. 6, gelatin, glycerin,

light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethyl cellulose,

sorbitol solution, soya lecithin, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel

TopCare health™

COMPARE TO SENOKOT® ACTIVE INGREDIENT*

Laxative

SENNOSIDES 8.6 mg • LAXATIVE

Gentle, Overnight Relief

60 SOFTGELS

actual size

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 may indicate a serious condition.

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

ask a health professional before use.

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 right away.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Sennosides 8.6 mg

Ask A Doctor Before Using If You Have (Ask a doctor before using 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

All Sections (JSON)