Your browser does not support JavaScript! MINERAL OIL ENEMA [DYNAREX CORPORATION]
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MINERAL OIL enema
[Dynarex Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active Ingredient                            Purpose

Mineral Oil, 100%                    Lubricant Laxative            

Uses:

  • Gentle relief of occasional constipation

Warnings:

For rectal use only



As a doctor before use if you have:

  • abdominal pain, nausea or vomiting
  • notice a sudden change in bowel habits that persists over a period of 2 weeks

  • If pregnant or breast feeding, ask a health professional before use.

Stop use and ask a doctor if:

  • If you have rectal bleeding or failure to have a bowel movement after use of a laxative because this amy indicate a serious condition
  • you need to use a laxative for more than one week

Keep out of reach of children

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Other information:

  • Store at room temperature 20 Deg C - 25 Deg C (68 Deg F - 77 Deg F)
  • This product produces bowel movement in 2 to 15 minutes

Directions

Single daily dose

Adults and children 12 years and older - 1 bottle

Children 2 to under 12 years - 1/2 bottle

Children under 2 years - Do not use. Consult a physician.


How to use this enema:

REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING.

Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with the other hand and pull gently to remove.

See image on box

Positioning

Left-side position: Lie on left side with knee bent and arms at rest.

See image on box

Knee-chest position: Kneel, then lower head and chest forward until the left side of face is resting on surface. Position arms comfortably.

See image on box

Administering Enema

  • With steady pressure, gently insert enema with tip pointing toward navel.
  • Squeeze bottle until recommended dose is expelled (it is not necessary to

    empty unit completely. Bottle contains more liquid than needed for effective

    use. A small amount of liquid will remain in bottle after squeezing).

  • Remove tip from rectum.

  • Stop using if tip is hard to insert. Forcing the tip into the rectum can

    cause injury (especially if you have hemorrhoids). If enema tip causes

    rectal bleeding or pain, get immediatemedical care.

  • Maintain position until urge to evacuate is strong (usually 1 to 5 minutes).

  • If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor

    promptly if no liquid comes out of the rectum after 30 minutes because

    dehydration could occur.

Principal Display Panel

Mineral oil enema.jpg

Mineral oil enema

MINERAL OIL 
mineral oil enema
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67777-401
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL118 mg  in 118 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-401-0148 in 1 CASE
11 in 1 BOX
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/29/2012
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Pvt. Ltd.864201135manufacture(67777-401)

Revised: 2/2013
 
Dynarex Corporation

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