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Drug Facts
Sunmark Mineral Oil Enema
FDA Label NDC 49348-185
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services for the product Sunmark Mineral Oil (NDC 49348-185). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each 118 ml delivered dose), purpose, use, warnings, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 over | 1 bottle |
| Children 2 to under 12 years old | 1/2 bottle once daily |
| Children under 2 years | DO 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)
Principal Display Panel (133 ml Bottle Carton)
* Please review the disclaimer below.
