Stool Softener by Bene Health OTC / Geri-Care Pharmaceutical Corp ben 408

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by Bene Health OTC, Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STOOL SOFTENER- docusate sodium capsule, liquid filled 
Bene Health OTC

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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ben 408

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

Take only by mouth.

• Adults and children 12 years of age and older: 1 to 3 softgels daily. ; 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: Ask a doctor

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&C red #40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. Also contains D&C yellow #10
or FD&C yellow #6 (sunset yellow).

Package Label

STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65155-408
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	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	A92
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65155-408-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/01/2020	03/01/2022

Labeler - Bene Health OTC (830110347)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Establishment
Name	Address	ID/FEI	Business Operations
Geri-Care Pharmaceutical Corp		611196254	pack(65155-408)

Revised: 12/2021

Document Id: d22ec316-0ea3-52a0-e053-2a95a90abdf3

34390-5

Set id: a7abbcf2-2b3b-6999-e053-2995a90ae726

Version: 2

Effective Time: 20211202