valumeds stool softener

valumeds stool softener
SPL v4
SPL
SPL Set ID 5ebc8cbc-b896-405f-8a23-14bcd0a70353
Route
oral
Published
Effective Date 2018-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Purpose

Stool Softner laxative

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Purpose

Stool Softner laxative

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.

Description

Drug Facts

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

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
Questions Or Comments?

1-888-333-9792

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

Purpose

Stool Softner laxative

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.

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

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

uses (Uses)
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces a bowel movement within 12 to 72 hours
Questions Or Comments? (Questions or comments?)

1-888-333-9792

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


Raw Label Data

All Sections (JSON)