HARRIS TEETER- mineral oil

Harris Teeter by

Drug Labeling and Warnings

Harris Teeter by is a Otc medication manufactured, distributed, or labeled by Harris Teeter, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

active ingredients

mineral oil 99.9%

Purpose

Lubricant laxative

Use

for relief of occasional constipation (irregularity).  Generally produces bowel movement in 6 to 8 hours

Do not use

• if you have difficulty swallowing
• in children under 6 years of age
• if you are pregnant
• for a period longer than 1 week
• if you are bedridden or aged

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

Ask a doctor or pharmacist before use if you are

• presently taking a stool softener laxative
• taking any other drug.  Take this product 2 or more hours before or after other drugs.  Laxatives may affect how other drugs work.

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 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 right away.

Direction

• do not take with meals
• take only at bedtime
• may be taked 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

childrebn 6 to 12 yeard of age - 1 to 3 teaspoons (15 mL) in 24 hours

children under 6 years of age - do not use, consult a doctor

Other information

keep tightly closed.  Protect from sunlight

Inactive ingredients

mixed tocopherols (added as a stabilizer)

Questions?

Call 1-888-593-0593

adverse reactions

PRODULY DISTRIBUTED BY: HARRIS TEETER, LLC MATTHEWS, NC 28105

1-800-432-6111

831.000/831AA

principal display panel

Harris Teeter

MINERAL OIL

U.S.P.

LUBRICANT LAXATIVE

FOR RELIEF OF OCASIONAL CONSTIPATION

ODORLESS - TASTELESS - COLORLESS

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

16 FL OZ (1 PT) 473 mL

INGREDIENTS AND APPEARANCE

HARRIS TEETER 
mineral oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69256-831
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	999 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69256-831-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/03/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/03/2017

Labeler - Harris Teeter (048463103)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(69256-831)