Gnp Docusate Liquid

Gnp Docusate Liquid
SPL v2
SPL
SPL Set ID 3bcab14d-a4b2-433a-9d1f-5dec61c7ae24
Route
ORAL
Published
Effective Date 2019-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Red No. 33 Methylparaben Propylparaben Polyethylene Glycol Sodium Citrate Water Poloxamer 407 Sucrose Sorbitol

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-09-01

Description

Docusate Sodium 50 mg

Purpose

Stool Softener Laxative


Medication Information

Purpose

Stool Softener Laxative

Description

Docusate Sodium 50 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a poison control Center right away.

Section 53414-9

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

Warnings

Do not use for more than one week unless directed by a doctor

Ask a doctor before use if you

  • have abdominal pain, nausea, or vomiting
  • are taking mineral oil
  • have noticed a sudden change in bowel habits that lasts more than 14 days

Stop use and ask a doctor if

  • you have rectal bleeding or failure to have a bowel movement within 3 days. These could be signs of a serious condition.
  • a skin rash occurs
  • you experience throat irritation
Directions
  • follow dosing directions below or take as directed by doctor
  • must be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritation
  • may be taken as a single daily dose or in divided doses
  • take maximum daily dose until first bowel movement, then reduce dose according to individual response
  • shake well before using

Adults and children 12 years and over

1 to 4 teaspoonfuls (5 to 20 mL)

Children under 12 years of age

ask a doctor

Package Label

NDC 17856-0398-1

Compare to Colace® Liquid active ingredient *

GOOD NEIGHBOR PHARMACY

STOOL

SOFTENER

LIQUID

Docusate Sodium

Relieves Constipation

250mg/25 mL 

50 cups per case

NDC 17856-0398-2

Compare to Colace® Liquid active ingredient *

GOOD NEIGHBOR PHARMACY

STOOL

SOFTENER

LIQUID

Docusate Sodium

Relieves Constipation

100mg/10 mL

72 cups per case

Other Information
  • Each teaspoonful contains: sodium 15 mg
  • Store at room temperature 15°- 30° C (59°-86° F)
  • protect from excessive heat
  • Keep tightly closed
Inactive Ingredients

citric acid, D&C Red #33, flavor, parabens, poloxamer, polyethylene glycol, sodium citrate, sorbitol, sucrose, and water.

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16TH PLACE 

MIAMI, FL 33179

Active Ingredient (in Each 5 Ml Teaspoonful)

Docusate Sodium 50 mg


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
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.

Section 53414-9 (53414-9)

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

Purpose

Stool Softener Laxative

Warnings

Do not use for more than one week unless directed by a doctor

Ask a doctor before use if you

  • have abdominal pain, nausea, or vomiting
  • are taking mineral oil
  • have noticed a sudden change in bowel habits that lasts more than 14 days

Stop use and ask a doctor if

  • you have rectal bleeding or failure to have a bowel movement within 3 days. These could be signs of a serious condition.
  • a skin rash occurs
  • you experience throat irritation
Directions
  • follow dosing directions below or take as directed by doctor
  • must be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritation
  • may be taken as a single daily dose or in divided doses
  • take maximum daily dose until first bowel movement, then reduce dose according to individual response
  • shake well before using

Adults and children 12 years and over

1 to 4 teaspoonfuls (5 to 20 mL)

Children under 12 years of age

ask a doctor

Package Label (package label)

NDC 17856-0398-1

Compare to Colace® Liquid active ingredient *

GOOD NEIGHBOR PHARMACY

STOOL

SOFTENER

LIQUID

Docusate Sodium

Relieves Constipation

250mg/25 mL 

50 cups per case

NDC 17856-0398-2

Compare to Colace® Liquid active ingredient *

GOOD NEIGHBOR PHARMACY

STOOL

SOFTENER

LIQUID

Docusate Sodium

Relieves Constipation

100mg/10 mL

72 cups per case

Other Information (Other information)
  • Each teaspoonful contains: sodium 15 mg
  • Store at room temperature 15°- 30° C (59°-86° F)
  • protect from excessive heat
  • Keep tightly closed
Inactive Ingredients (Inactive ingredients)

citric acid, D&C Red #33, flavor, parabens, poloxamer, polyethylene glycol, sodium citrate, sorbitol, sucrose, and water.

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16TH PLACE 

MIAMI, FL 33179

Active Ingredient (in Each 5 Ml Teaspoonful) (Active ingredient (in each 5 mL teaspoonful))

Docusate Sodium 50 mg


Advanced Ingredient Data


Raw Label Data

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