Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a39b6b6c-e2f2-4c97-bf22-8ba01e72dc03
Routes
TOPICAL ORAL
Published
Effective Date 2009-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (15 mL)
Inactive Ingredients
Alpha-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2009-04-02

Description

Mineral Oil


Medication Information

Description

Mineral Oil

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 6 to 8 hours

Section 55105-1

intestinal lubricant

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





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

Active Ingredient

Mineral Oil

Other Information

keep tightly closed

protect from sunlight



Inactive Ingredient

d-alpha tocopherol (Vitamin E) as stabilizer

Principal Display Panel


Walgreens



Mineral Oil



When Using This Product

do not take with meals

take only at bedtime

If Pregnant Or Breast Feeding,

ask a health professional before use

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



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

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


Structured Label Content

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 6 to 8 hours

Section 55105-1 (55105-1)

intestinal lubricant

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





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

Active Ingredient

Mineral Oil

Other Information

keep tightly closed

protect from sunlight



Inactive Ingredient

d-alpha tocopherol (Vitamin E) as stabilizer

Principal Display Panel


Walgreens



Mineral Oil



When Using This Product (When using this product)

do not take with meals

take only at bedtime

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professional before use

Ask A Doctor Before Use If You Have (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



Stop Use and Ask A Doctor If You Have (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

Keep This and All Drugs Out of the Reach of Children (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


Advanced Ingredient Data


Raw Label Data

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