HARRIS TEETER- mineral oil 
Harris Teeter

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Harris Teeter 831.000-AA

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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

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

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 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

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

image description

HARRIS TEETER 
mineral oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69256-831
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL999 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69256-831-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/03/2017
Labeler - Harris Teeter (048463103)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(69256-831)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(69256-831)

Revised: 5/2022
Document Id: 3df488a8-1d29-4140-8737-8811427accf5
Set id: 401e3a7e-54be-47cc-88c3-a343f5cbbd10
Version: 11
Effective Time: 20220512
 
Harris Teeter