Mineral Oil by Walgreens / Aaron Industries Inc. MINERAL OIL oil

Mineral Oil by

Drug Labeling and Warnings

Mineral Oil by is a Otc medication manufactured, distributed, or labeled by Walgreens, Aaron Industries Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

                                                          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

Walgreens

Mineral Oil

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0360
Route of Administration	TOPICAL, ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	15 mL  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: 0363-0360-16	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/02/2009

Labeler - Walgreens (008965063)

Registrant - Aaron Industries Inc. (030119387)

Establishment
Name	Address	ID/FEI	Business Operations
Aaron Industries Inc.		030119387	manufacture, analysis