Healthmart Mineral Oil Single Enema
FDA Label NDC 62011-0270

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Healthmart Mineral Oil Single (NDC 62011-0270). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each 118 ml delivered dose), purpose, use, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient (in Each 118 Ml Delivered Dose)

→ Purpose

→ Use

→ Warnings

→ Otc - Ask Doctor

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 133 Ml Bottle Carton

Other

Drug Facts

Distributed by McKesson
One Post Street, San Francisco, CA 94104

Active Ingredient (In Each 118 Ml Delivered Dose)

Mineral Oil 100%

Purpose

Lubricant laxative

Use

for relief of occasional constipation

Warnings

For rectal use only.

Otc - Ask Doctor

Ask a doctor before use if you have

abdominal pain, nausea, or vomiting
a sudden change in bowel habits lasting more than 2 weeks
already used a laxative for more than 1 week

Otc - Stop Use

Stop use and ask a doctor if you have:

rectal bleeding
no bowel movement after use

These symptoms may indicate a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

Single daily dosage

Do not use more unless directed by a doctor. See Warnings.

Adults and children 12 years old and over	1 bottle
Children 2 to under 12 years old	1/2 bottle once daily
Children under 2 years	DO NOT USE

Other Information

store at 15 to 30°C (59 to 86°F)
this product generally produces a bowel movement in 1-5 minutes
carton sealed for safety. Do not use if safety seal on top flap of carton is torn or missing.