private label mineral oil heavy

private label mineral oil heavy
SPL v1
SPL
SPL Set ID a8c1f436-e5dd-0cc0-e053-2a95a90a2d16
Route
oral
Published
Effective Date 2018-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
mineral oil (1000 mg)
Inactive Ingredients
.alpha.-tocopherol acetate, dl-

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2018-12-18

Purpose

Laxative

Description

Drug Facts


Medication Information

Warnings

Do not take this product if you have abdominal pain, nausea, vomiting, change in bowel habits persisting more than 2 weeks, rectal bleeding or kidney failure are present, or use for a period of longer than 1 week unless directed by a doctor. Frequent or prolonged use may result in the dependence on laxatives.

Do not administer to infants or young children, bedridden or aged patients unless directed by a doctor.

Purpose

Laxative

Directions

Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime.

Children 6 to 12 yrs. of age: 1 to 3 teaspoonfuls at bedtime.

Children under 6 yrs. of age: Consult a doctor before use.

Other Information

Keep tightly closed and protect from direct light.

Description

Drug Facts

Use

For relief of occasional constipation or irregularit. Generally produces bowel movement in 6 to 8 hrs.

Section 42229-5

Drug Facts

Cvs Label

Leader Label

Active Ingredient

Mineral Oil Heavy

Inactive Ingredient

dl-alpha-tocopherol as a preservative.

Ask A Doctor Before Use If

you are currently taking a stool softener laxative.

If pregnant or brest feeding ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.

When Using This Product Discotinue Use

and consult a doctor if there is a failure to have a bowel movement after use.


Structured Label Content

Warnings

Do not take this product if you have abdominal pain, nausea, vomiting, change in bowel habits persisting more than 2 weeks, rectal bleeding or kidney failure are present, or use for a period of longer than 1 week unless directed by a doctor. Frequent or prolonged use may result in the dependence on laxatives.

Do not administer to infants or young children, bedridden or aged patients unless directed by a doctor.

Purpose

Laxative

Directions

Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime.

Children 6 to 12 yrs. of age: 1 to 3 teaspoonfuls at bedtime.

Children under 6 yrs. of age: Consult a doctor before use.

Other Information (Other information)

Keep tightly closed and protect from direct light.

Use

For relief of occasional constipation or irregularit. Generally produces bowel movement in 6 to 8 hrs.

Section 42229-5 (42229-5)

Drug Facts

Cvs Label (CVS Label)

Leader Label

Active Ingredient (Active ingredient)

Mineral Oil Heavy

Inactive Ingredient (Inactive ingredient)

dl-alpha-tocopherol as a preservative.

Ask A Doctor Before Use If (Ask a doctor before use if)

you are currently taking a stool softener laxative.

If pregnant or brest feeding ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.

When Using This Product Discotinue Use (When using this Product discotinue use)

and consult a doctor if there is a failure to have a bowel movement after use.


Advanced Ingredient Data


Raw Label Data

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