DOCUSATE SODIUM- docusate sodium capsule, liquid filled
AiPing Pharmaceutical, 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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Docusate Sodium capsule, liquid filled (single-tone)

ACTIVE INGREDIENT (IN EACH SOFTGEL)

Docusate Sodium 100mg

PURPOSE

Stool softener

USES

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

WARNINGS

Do Not Use

if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
you need to use a stool softener laxative for more than 1 week

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. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over: take 1-3 softgels daily
children 2 to under 12 years of age: take 1 softgel daily
children under 2 years: ask a doctor

OTHER INFORMATION

each softgel contains: sodium 6 mg;
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

Keep tigtly closed.

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING

INACTIVE INGREDIENTS

D&C Red #33, FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink.

QUESTIONS OR COMMENTS?

Call 1-844-374-0016

PRINCIPAL DISPLAY PANEL

Manufactured for:

AiPing Pharmaceutical, Inc.

Hauppauge, NY 11788

Manufactured by:

Anshi Pharmaceutical (Zhongshan) Inc., P.R. China

dss 1-tone bottle

DOCUSATE SODIUM
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11788-024
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	AP024
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11788-024-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	11/01/2018	12/31/2019

Labeler - AiPing Pharmaceutical, Inc. (079674526)

Registrant - AiPing Pharmaceutical, Inc. (079674526)

Name	Address	ID/FEI	Business Operations
Establishment
Anshi Pharmaceutical (Zhongshan) Inc.		528101821	manufacture(11788-024) , analysis(11788-024) , label(11788-024) , pack(11788-024)

Revised: 5/2021

Document Id: c32957ce-d73b-72cf-e053-2995a90a2538

Set id: 34670b19-8ce0-43c4-a34c-5ea2168d1cd2

Version: 9

Effective Time: 20210525

AiPing Pharmaceutical, Inc.