STOOL SOFTENER LIQUID- docusate sodium liquid

Stool Softener Liquid by

Drug Labeling and Warnings

Stool Softener Liquid by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL teaspoonful)

Docusate Sodium 50 mg

Purpose

Stool Softener Laxative

Uses

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

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

PREGNANCY 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.

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

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

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

INGREDIENTS AND APPEARANCE

STOOL SOFTENER LIQUID 
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-0398(NDC:46122-399)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SUCROSE (UNII: C151H8M554)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-0398-1	50 in 1 BOX, UNIT-DOSE	08/06/2019
1		25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 17856-0398-2	72 in 1 BOX, UNIT-DOSE	08/06/2019
2		10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/01/2017

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
ATLANTIC BIOLOGICALS CORP.		047437707	relabel(17856-0398) , repack(17856-0398)