Valumeds Stool Softener

Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

Polyethylene Glycol 400 Propylene Glycol Water Gelatin Glycerin Sorbitol Fd&c Red No. 40 Fd&c Yellow No. 6 Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 125 Shape: capsule Color: red Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2018-04-10

Medication Information

Warnings and Precautions

Warnings

Purpose

Stool Softner laxative

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

Section 50568-5

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Section 53414-9

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

uses

for temporary relief of occasional constipation and irregularity
this product generally produces a bowel movement within 12 to 72 hours

Directions

take with a glass of water

Adults and children 12 years and over	1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses
Children 2 to under 12 years of age	1 softgel daily.
Children under 2 years of age	Ask a doctor

Other Information

Store at room temperature 20-25°C (68-77°F)
protect from excessive humidity
do not use this product of the safety seal under the cap is torn or missing

Inactive Ingredients

FD&C Red#40, FD&C Yellow#6, gelatin,glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.

Questions Or Comments?

1-888-333-9792

Principal Display Panel

VALUMEDS ^TM

Compare to the active ingredient in

Dulcolax ^®Stool Softener ^*

STOOL SOFTENER

DOCUSATE SODIUM 100 mg

Gentle,Stimulant-Free Relief

Constipation Relief

30 SOFTGELS

Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg

stop Use and Ask A Doctor If You

you have rectal bleeding ot no bowel movement after using this product. These could be signs of a serious condition.
yo need to use laxative for more than 1 week

ask A Doctor Before Use If You Have

stomach pain, nausea or vomittiong
a sudden change in bowel habits that lasts more than 2 weeks

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Section 53414-9 (53414-9)

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

Purpose

Stool Softner laxative

uses (Uses)

for temporary relief of occasional constipation and irregularity
this product generally produces a bowel movement within 12 to 72 hours

Directions

take with a glass of water

Adults and children 12 years and over	1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses
Children 2 to under 12 years of age	1 softgel daily.
Children under 2 years of age	Ask a doctor

Other Information (Other information)

Store at room temperature 20-25°C (68-77°F)
protect from excessive humidity
do not use this product of the safety seal under the cap is torn or missing

Inactive Ingredients (Inactive ingredients)

FD&C Red#40, FD&C Yellow#6, gelatin,glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL-)

VALUMEDS ^TM

Compare to the active ingredient in

Dulcolax ^®Stool Softener ^*

STOOL SOFTENER

DOCUSATE SODIUM 100 mg

Gentle,Stimulant-Free Relief

Constipation Relief

30 SOFTGELS

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

Docusate Sodium 100 mg

stop Use and Ask A Doctor If You (Stop use and ask a doctor if you)

you have rectal bleeding ot no bowel movement after using this product. These could be signs of a serious condition.
yo need to use laxative for more than 1 week

ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

stomach pain, nausea or vomittiong
a sudden change in bowel habits that lasts more than 2 weeks

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34071-1": "Warnings", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222", "50568-5": "Ask a doctor or pharmacist before use if you are presently taking mineral oil", "53414-9": "If pregnant or breast-feeding ,ask a health professional before use", "Purpose": "Stool Softner laxative", "Uses": "for temporary relief of occasional constipation and irregularity this product generally produces a bowel movement within 12 to 72 hours", "Directions": "take with a glass of water Adults and children 12 years and over 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses Children 2 to under 12 years of age 1 softgel daily. Children under 2 years of age Ask a doctor", "Other information": "Store at room temperature 20-25°C (68-77°F) protect from excessive humidity do not use this product of the safety seal under the cap is torn or missing", "Inactive ingredients": "FD&C Red#40, FD&C Yellow#6, gelatin,glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.", "Questions or comments?": "1-888-333-9792", "PRINCIPAL DISPLAY PANEL-": "VALUMEDS TM Compare to the active ingredient in Dulcolax ® Stool Softener * STOOL SOFTENER DOCUSATE SODIUM 100 mg Gentle,Stimulant-Free Relief Constipation Relief 30 SOFTGELS", "Active ingredient (in each softgel)": "Docusate Sodium 100 mg ", "Stop use and ask a doctor if you": "you have rectal bleeding ot no bowel movement after using this product. These could be signs of a serious condition. yo need to use laxative for more than 1 week", "Ask a doctor before use if you have": "stomach pain, nausea or vomittiong a sudden change in bowel habits that lasts more than 2 weeks"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information