Mineral Oil by Galentic Pharma (India) Priva Te Limited MINERAL OIL enema

Mineral Oil by

Drug Labeling and Warnings

Mineral Oil by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Priva Te Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Galentic Mineral Oil Enema

Gal Enema Min Oil.jpg

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-009
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	118 g  in 118 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-009-01	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/07/2013

Labeler - Galentic Pharma (India) Priva Te Limited (918531450)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Priva Te Limited		918531450	manufacture(50382-009)