Mineral Oil by Rite Aid Corporation Drug Facts

Mineral Oil by

Drug Labeling and Warnings

Mineral Oil by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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) 

                                                          maximum3 tablespoons (45mL) in 24 hours

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

                                                          maximum 3 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

Lubricant Laxative

Odorless   Tasteless   Colorless

Important: Read other side of label

Distributed by Rite Aid Corporation

30 Hunter Lane, Camp Hill,   PA  17011

16 FL. OZ. 1 PT 473 mL

MINERAL OIL 
mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-3601
Route of Administration	ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	15 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-3601-6	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/16/2009	12/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	04/16/2009	12/30/2019

Labeler - Rite Aid Corporation (014578892)

Revised: 9/2019

Document Id: 411f5fb9-2bf4-48a4-bd80-3a28def443ea

34390-5

Set id: b24409f9-345b-4766-84fc-14f7becb1532

Version: 5

Effective Time: 20190927