Senna Softgels

Senna Softgels
SPL v7
SPL
SPL Set ID a5652d5b-43fd-5bfa-e053-2995a90aad6c
Route
ORAL
Published
Effective Date 2019-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (17.2 mg)
Inactive Ingredients
Glycerin Methylparaben Water Yellow Wax Fd&c Blue No. 1 Soybean Oil Fumaric Acid Food Yellow 3 Free Acid Sorbitol Titanium Dioxide Lecithin, Soybean Fd&c Blue No. 2 Fd&c Red No. 40 Gelatin

Identifiers & Packaging

Pill Appearance
Shape: oval Color: brown Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-31

Description

(in each softgel) Sennosides 17.2 mg

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

(in each softgel) Sennosides 17.2 mg

Uses

■ relieves occasional constipation (irregularity)

■ generally produces a bowel movement within 6-12 hours

Directions

■ take preferably at bedtime or as directed by a doctor.

adults and children 12 years and over

■ 1 capsule once a day. Maximum 2 capsules twice a day.

children 6 to under 12 years

■ maximum 1 capsule twice a day

children under 6 years

■ ask a doctor

Do Not Use

■ laxative products for longer than 1 week unless directed by a doctor

Active Ingredient

(in each softgel)

Sennosides 17.2 mg

Other Information

■ store below 30°C and protect from light and moisture

Inactive Ingredients

FD&C blue no.1, FD&C blue no.2, FD&C red no. 40, FD&C yellow no.6, fumaric acid, gelatin, glycerol, lecithin, liquid sorbitol, methyl hydroxy benzoate, purified water, refined soya oil, titanium dioxide, yellow bees wax.

Questions Or Comments?

call 1-877-770-3183: weekdays 9:00 AM to 4:30 PM EST.

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

Stop Use and Consult 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.

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

Package Label Principal Display Panel


Structured Label Content

Uses

■ relieves occasional constipation (irregularity)

■ generally produces a bowel movement within 6-12 hours

Purpose

Laxative

Directions

■ take preferably at bedtime or as directed by a doctor.

adults and children 12 years and over

■ 1 capsule once a day. Maximum 2 capsules twice a day.

children 6 to under 12 years

■ maximum 1 capsule twice a day

children under 6 years

■ ask a doctor

Do Not Use (Do not use)

■ laxative products for longer than 1 week unless directed by a doctor

Active Ingredient

(in each softgel)

Sennosides 17.2 mg

Other Information (Other information)

■ store below 30°C and protect from light and moisture

Inactive Ingredients (Inactive ingredients)

FD&C blue no.1, FD&C blue no.2, FD&C red no. 40, FD&C yellow no.6, fumaric acid, gelatin, glycerol, lecithin, liquid sorbitol, methyl hydroxy benzoate, purified water, refined soya oil, titanium dioxide, yellow bees wax.

Questions Or Comments? (Questions or comments?)

call 1-877-770-3183: weekdays 9:00 AM to 4:30 PM EST.

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

Stop Use and Consult A Doctor If (Stop use and consult 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.

Ask A Doctor Before Use If You Have (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

Package Label Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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