FDA Label for Sunmark Mineral Oil Laxative

View Indications, Usage & Precautions

Sunmark Mineral Oil Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Mckesson. 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.

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Drug Facts


Active Ingredient (In Each 118 Ml Delivered Dose)



Mineral Oil 100%


Purpose



Lubricant laxative


Use



  • for relief of occasional constipation

Warnings



For rectal use only.


Otc - Ask Doctor



Ask a doctor before use if you have

  • abdominal pain, nausea, or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

Otc - Pregnancy Or Breast Feeding



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


Otc - 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: 800-222-1222.


Directions



Single daily dosage

Do not use more unless directed by a doctor. See Warnings.

Adults and children 12 years old and over1 bottle
Children 2 to under 12 years old1/2 bottle once daily
Children under 2 yearsDO NOT USE

Other Information



  • store at 15 to 30°C (59 to 86°F)
  • this product generally produces a bowel movement in 1-5 minutes
  • carton sealed for safety. Do not use if safety seal on top flap of carton is torn or missing.

Inactive Ingredients



none


Questions Or Comments?



866-323-0107 or www.natureplex.com


Principal Display Panel - 133 Ml Bottle Carton



sunmark®

COMPARE TO FLEET®
MINERAL OIL ENEMA
ACTIVE INGREDIENT*

NDC 49348-185-20

complete
ready-to-use

enema

Mineral Oil

Sodium free lubricant
laxative for relief of
occasional constipation

Comfortable,
lubricated tip

Works in minutes

NOT MADE WITH
NATURAL RUBBER
LATEX

4.5 FL OZ
(133 ml)


* Please review the disclaimer below.