Stool Softener by NuCare Pharmaceuticals, Inc.

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by NuCare Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STOOL SOFTENER- docusate sodium capsule, liquid filled 
NuCare Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses

• relieves occasional constipation (irregularity)

• generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you

have stomach pain, nausea or vomiting

have a sudden change in bowel habits that persists over a period of 2 weeks

are presently taking mineral oil

Stop use and ask a doctor if

you need to use a laxative longer than 1 week

you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

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

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

Directions

adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor

children under 12: consult a doctor

do not exceed recommended dose

Other information

each softgel contains: sodium 5 mg. very low sodium

store at 15°C-25°C(59° F-77° F)

keep tightly closed

product from USA or Canada

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

FD and C red 40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow 10, FD and C yellow 6 (sunset yellow), mannitol.

Package Label

STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66267-083(NDC: 57896-401)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	red (reddish)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SCU1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66267-083-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2016
2	NDC: 66267-083-40	40 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2016
3	NDC: 66267-083-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/01/2000	12/31/2018

Labeler - NuCare Pharmaceuticals, Inc. (010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals, Inc.		010632300	repack(66267-083)

Revised: 3/2020

Document Id: a216df3e-896c-20d4-e053-2995a90ad721

34390-5

Set id: 3dbe63b3-9080-4a1a-e054-00144ff88e88

Version: 3

Effective Time: 20200330