Foster & Thrive™ Ready To Use Enema Mineral Oil

Foster & Thrive™ Ready To Use Enema Mineral Oil
SPL v3
SPL
SPL Set ID ea6da66c-6825-4cd7-8791-45b537bf203a
Route
RECTAL
Published
Effective Date 2024-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (1000 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-09

Description

Drug Facts

Purpose

Lubricant laxative


Medication Information

Purpose

Lubricant laxative

Description

Drug Facts

Use
  • for relief of occasional constipation
  • this product generally produces bowel movement in 2 to 15 minutes
Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

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

Warnings

For rectal use only.

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

Stop Use and Ask A Doctor If
  • you have rectal bleeding
  • you fail to have a bowel movement after use
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
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 older 1 bottle
Children 2-12 years old 1/2 bottle
Children under 2 years old DO NOT USE
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)

Active Ingredients (in Each 118ml Delivered Dose)

Mineral oil 100%


Structured Label Content

Use
  • for relief of occasional constipation
  • this product generally produces bowel movement in 2 to 15 minutes
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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

Purpose

Lubricant laxative

Warnings

For rectal use only.

Other Information (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 (Inactive ingredients)

none

Questions Or Comments? (Questions or comments?)

833-358-6431

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding
  • you fail to have a bowel movement after use
Ask A Doctor Before Use If You (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
Directions (or As Directed By A Doctor) (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 older 1 bottle
Children 2-12 years old 1/2 bottle
Children under 2 years old DO NOT USE
Principal Display Panel 133 Ml Bottle Carton (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)

Active Ingredients (in Each 118ml Delivered Dose) (Active ingredients (in each 118mL delivered dose))

Mineral oil 100%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)