Mineral oil by P & L Development, LLC MINERAL OIL oil

Mineral oil by

Drug Labeling and Warnings

Mineral oil by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Mineral oil 100%

Purpose

Lubricant laxative

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 6 to 8 hours

Warnings

Do not use

• in children under 12 years of age, pregnant women, bedridden patients or aged, or if you have difficulty swallowing
• if you are presently taking a stool softener laxative
• for longer than 1 week

Ask a doctor before use if you have

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

When using this product

• do not take with meals
• take only at bedtime

Stop use and ask a doctor if

you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• do not take with meals
• take only at bedtime
• may be taken as a single daily dose or in divided doses
• adults and children 12 years of age and over
  • 1 to 3 tablespoons (15 to 45 mL)
  • maximum 3 tablespoons (45 mL) in 24 hours
• children under 12 years, consult a doctor

Other information

• keep tightly closed
• protect from direct light

Inactive ingredients

Vitamin E as stabilizer

Principal Display Panel

Mineral Oil

lubricant laxative

• odorless
• tasteless
• colorless

FL OZ (mL)

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Manufactured by:

PL Developments

1874 Hwy 72 W,

Clinton, SC 29325

Package Label

ReadyinCase Mineral Oil

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49580-0334
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	100 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49580-0334-6	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	08/31/2014

Labeler - P & L Development, LLC (101896231)