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

Purpose

Laxative

Description

(in each softgel) Sennosides 17.2 mg


Medication Information

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

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.

Description

(in each softgel) Sennosides 17.2 mg

Do Not Use

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

Active Ingredient

(in each softgel)

Sennosides 17.2 mg

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

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.

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

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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