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  5. Label Information: Cvs Adult Enema

FDA Label for Cvs Adult Enema

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. STOP USE AND ASK A DOCTOR IF
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. OTC - QUESTIONS
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cvs Adult Enema Product Label

The following document was submitted to the FDA by the labeler of this product Summit Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts



Active Ingredients (in each delivered dose)

Benzocaine 20 mg

Docusate Sodium USP 283 mg


Purpose



Benzocaine 20mg..................................................................Anesthetic

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


Uses



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

Warnings



For rectal use only


Do Not Use



  • If individual is sensitive to Benzocaine.
  • If you are presently taking mineral oil, unless directed by a doctor.
  • When abdomen pain, nausea or vomiting are present.
  • For a period longer than 1 week unless directed by a doctor.

Stop Use And Ask A Doctor If



  • Symptoms last more than 2 weeks.
  • You have rectal bleeding or fail to have a bowel movement after use. This may indicate a serious condition.

Otc - Pregnancy Or Breast Feeding



Pregnant or lactating women, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



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 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 tube's liquid content on the shaft prior to insertion. Also apply liquid content or lubricant to the anus before inserting the mini-enema.
  • Positioning: For best results, lay on 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. Insert up to the shoulder of tube. 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



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


Inactive Ingredients



Glycerine USP and Polyethylene Glycol


Otc - Questions



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