MINERAL OIL- mineral oil oil 
Rite Aid Corporation

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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Drug Facts

Active Ingredient

Mineral Oil

purpose

intestinal lubricant

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 6 years of age

if you are pregnant

for a period longer than one 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


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 this and all drugs out of the reach of children

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately

Directions

do not take with meals

take only at bedtime

may be taken as a single daily dose or in divided doses

age                                                      dose

adults and children over 12 years         1 to 3 tablespoons (15 to 45 ml) 

                                                          maximum 3 tablespoons (45mL) in 24 hours

children 6 years to under 12 years         1 to 3 tablespoons (15 to 45 ml) 

                                                          maximum3 tablespoons (45mL) in 24 hours

children under 6 years                           do not use, consult a doctor

Other Information

keep tightly closed

protect from sunlight


Inactive Ingredient

d-alpha tocopherol (Vitamin E) as stabilizer

Principal Display Panel

Rite

Aid

Pharmacy

Mineral Oil USP

Lubricant Laxative

Odorless  Tasteless    Colorless

IMPORTANT: Read other side of label

32 FL OZ 1QT 946 mL

image of label


MINERAL OIL 
mineral oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0603
Route of AdministrationORAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL15 mL  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-0603-2946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/200912/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33404/16/200912/30/2019
Labeler - Rite Aid Corporation (014578892)

Revised: 9/2019
 
Rite Aid Corporation