DOCUSOL- docusate sodium liquid 
Enemeez Inc. 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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Drug Facts

Active Ingredient (per mini enema)

Docusate Sodium USP 283 mg.............................Stool Softener Laxative

Uses

  • For relief of occasional constipation (irregularity).
  • This product generally produces a bowel movement in 2 to 15 minutes.

Warnings

For rectal use only.

Ask a doctor before use if:

  • abdominal pain, nausea or vomiting are present.
  • Laxative products are needed for a period longer than 1 week unless directed by a doctor.

Stop use and ask a doctor if you:

  • Rectal bleeding.
  • Noticed a sudden change in bowel habits that persist over a period of 2 weeks.
  • Failed to have a bowel movement after use. This may indicate a serious condition.

Pregnant or Lactating Women

Ask a health professional before use.

Keep out of reach of children

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

Uses

  • For relief of occasional constipation (irregularity). 
  • This product generally produces a bowel movement in 2 to 15 minutes.

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.

  • Twist off and remove tip.
  • Lubricate tip prior to insertion: Place a few drops of the tubes liquid content on the shaft prior to insertion. Also apply tubes liquid or lubricant to the anus before inserting the mini-enema.
  • Positioning: For best results, lay on the left side with knees bent. Alternate Positions: Administer while seated on the toilet. Or, kneel, then lower head and chest forward until side of face is resting on the surface.
  • With steady pressure, gently insert the tube into the rectum with care to prevent damage to the rectal wall.  Squeeze to empty the contents.  Keep the tube squeezed until it is removed from the rectum.  After the contents have been emptied, remove the disposable tube and discard.  A small amount of liquid may remain in the unit after use.

Other Information

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

Inactive Ingredients

Polyethylene Glycol and Glycerin USP

Questions or Comments: 1-888-273-9734


Distributed by:
Alliance Labs, L.L.C
Phoenix, AZ 85050

DocusolJar

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
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17433-9878-330 in 1 JAR03/26/201501/13/2023
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 finalpart33407/08/201301/13/2023
Labeler - Enemeez Inc. DBA Summit Pharmaceuticals (010717819)
Establishment
NameAddressID/FEIBusiness Operations
Enemeez Inc. DBA Summit Pharmaceuticals010717819manufacture(17433-9878)

Revised: 1/2023
 
Enemeez Inc. DBA Summit Pharmaceuticals