Mineral oil by Harris Teeter, LLC MINERAL OIL oil

Mineral oil by

Drug Labeling and Warnings

Mineral oil by is a Otc medication manufactured, distributed, or labeled by Harris Teeter, 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

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

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 overdose, 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
  • adult 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 closes
• protect from direct light

Inactive ingredients

Vitamin E as stabilizer

Principal Display Panel

Mineral Oil

Lubricant laxative

• Odorless
• Tasteless
• Colorless

FL OZ (mL)

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

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC

MATTHEWS, NC 28105

1-800-432-6111 or harristeeter.com

Package Label

Harris Teeter Mineral Oil

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69256-334
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: 69256-334-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2016	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	01/31/2016	12/31/2020

Labeler - Harris Teeter, LLC (048463103)