Foster And Thrive Ready To Use Mineral Oil Enema
FDA Label NDC 70677-1090

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 Foster And Thrive Ready To Use Mineral Oil (NDC 70677-1090). 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 ingredients (in each 118ml delivered dose), purpose, use, warnings, ask a doctor before use if you, stop use and ask a doctor if, 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

Drug Facts

Distributed by: McKesson Corp., via Strategic
Sourcing Services LLC. Memphis, TN 38141

Active Ingredients (In Each 118Ml Delivered Dose)

Mineral oil 100%

Purpose

Lubricant laxative

Use

  • for relief of occasional constipation
  • this product generally produces bowel movement in 2 to 15 minutes

Warnings

For rectal use only.

Ask A Doctor Before Use If You

  • have already used a laxative for more than 1 week
  • have abdominal pain, nausea, or vomiting
  • have a sudden change in bowel habits that persist over a period of 2 weeks

Stop Use And Ask A Doctor If

  • you have rectal bleeding
  • you fail to have a bowel movement after use

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 (Or As Directed By A Doctor)

Rectal enema dosage is 118 mL in a single daily dosage (per 24 hours).

Adults & children 13 years old and older1 bottle
Children 2-12 years old1/2 bottle
Children under 2 years oldDO NOT USE

Other Information

  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.

Inactive Ingredients

none

Questions Or Comments?

833-358-6431

Principal Display Panel - 133 Ml Bottle Carton

NDC 70677-1090-1

COMPARE TO FLEET®
MINERAL OIL ENEMA
ACTIVE INGREDIENTS*

Foster & Thrive™

READY TO USE
Enema
MINERAL OIL

Lubricated Tip

Sodium Free

Not Made With
Natural Rubber Latex

For Relief of:

  • Occassional
    Constipation

    • NOT ACTUAL SIZE
    1 BOTTLE
    4.5 FL OZ (133 mL)

    Principal Display Panel (133 mL Bottle Carton)

    Principal Display Panel (133 mL Bottle Carton)

* Please review the disclaimer below.