DOCUSOL- docusate sodium liquid 
Enemeez LLC DBA Summit Pharmaceuticals

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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DocuSol®

Drug Facts

Active Ingredient (per delivered dose)

Docusate Sodium USP 283 mg

Purpose

Stool Softener Laxative

Uses

Warnings

For rectal use only. Drug Interaction Precaution: Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

Do not use

Stop use and ask a doctor if you have:

Pregnant or Lactating Women

Ask a health professional before use.

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 12 years of age and older (with adult supervision) one to three units daily. Children under 12 years of age, consult a doctor prior to use.

Other Information

Store at room temperature 15° - 30° C (59° - 86° F)

Inactive Ingredients

Glycerin USP and Polyethylene Glycol

pdp

DOCUSOL 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17433-9878
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM283 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17433-9878-55 in 1 BOX07/08/201310/31/2024
1NDC:17433-9878-15 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/08/201310/31/2024
Labeler - Enemeez LLC DBA Summit Pharmaceuticals (010717819)
Establishment
NameAddressID/FEIBusiness Operations
Enemeez LLC DBA Summit Pharmaceuticals010717819manufacture(17433-9878)

Revised: 11/2022
Document Id: ecfb3572-aff3-375f-e053-2995a90ad328
Set id: f7cf7e06-8461-4172-9861-f0ad709d7c9f
Version: 8
Effective Time: 20221108
 
Enemeez LLC DBA Summit Pharmaceuticals