Only For

Only For
SPL v1
SPL
SPL Set ID 94a2acd4-5a94-4ce6-9180-38dad80ed20c
Route
ORAL
Published
Effective Date 2019-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Hypromellose 2910 (5 Mpa.s) Magnesium Palmitostearate Microcrystalline Cellulose 101 Polyethylene Glycol 400

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-03-29

Description

Sennosides 8.6 mg

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Sennosides 8.6 mg

Uses:

• relieves occasional constipation (irregularity)

• generally causes a bowel movement in 6‐12 hours

Section 42229-5

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Tear along perforation push product through foil

CT2LXN4-REV.102018

Packaging

Warnings:

Do not use:

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

Ask a doctor before use if you have

• stomach pain

• nausea

• vomiting

• noticed a sudden change in bowel habits that continue over a period of 2 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.

Drug Facts

Directions:
• do not take more than directed  • take with full glass of water

• 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

Other Information:

• Store at room temperature between 20-25°C (68-77°F).

Inactive Ingredients:

Croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol.

Questions Or Comments ?

1-833-665-9444.

Keep Out of Reach of Children

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Tablet)

Sennosides 8.6 mg


Structured Label Content

Uses:

• relieves occasional constipation (irregularity)

• generally causes a bowel movement in 6‐12 hours

Section 42229-5 (42229-5)

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Tear along perforation push product through foil

CT2LXN4-REV.102018

Purpose

Stimulant laxative

Packaging

Warnings:

Do not use:

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

Ask a doctor before use if you have

• stomach pain

• nausea

• vomiting

• noticed a sudden change in bowel habits that continue over a period of 2 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.

Drug Facts (DRUG FACTS)

Directions:
• do not take more than directed  • take with full glass of water

• 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

Other Information:

• Store at room temperature between 20-25°C (68-77°F).

Inactive Ingredients:

Croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol.

Questions Or Comments ?

1-833-665-9444.

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Sennosides 8.6 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)