DOCUSOL KIDS- 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® Kids

Drug Facts

Active Ingredient (per delivered dose)

Docusate Sodium USP 100 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

Children 2 years to under 12 years of age (with adult supervision) one unit daily. Children under 2 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

9884-5

pdp

DOCUSOL KIDS 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17433-9884
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 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:17433-9884-55 in 1 BOX01/14/201411/30/2025
1NDC:17433-9884-15 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 finalpart33401/14/201411/30/2025
Labeler - Enemeez LLC DBA Summit Pharmaceuticals (010717819)
Establishment
NameAddressID/FEIBusiness Operations
Enemeez LLC DBA Summit Pharmaceuticals010717819manufacture(17433-9884)

Revised: 1/2023
Document Id: f2288397-b059-8deb-e053-2995a90a75fc
Set id: 0d9355f0-d19f-4404-9b9e-bb2c874e39d6
Version: 8
Effective Time: 20230113
 
Enemeez LLC DBA Summit Pharmaceuticals