Foster And Thrive Ready To Use Saline Enema
FDA Label NDC 70677-1089

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Foster And Thrive Ready To Use Saline (NDC 70677-1089). 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, otc - purpose, use, dosage warning, do not use, ask a doctor before use if you, otc - ask doctor/pharmacist, when using this product, 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

Otc - Purpose

Active ingredients (in each 118mL delivered dose)Purpose
Dibasic Sodium Phosphate 7 gSaline laxative
Monobasic Sodium Phosphate 19 gSaline laxative

Use

  • relieves occasional constipation
  • this product generally produces bowel movement in 1 to 5 minutes

Dosage Warning

Using more than one enema in 24 hours can be harmful.

For rectal use only.

Do Not Use

  • on children under 2 years of age

Ask A Doctor Before Use If You

  • have already used a laxative for more than 3 days
  • have kidney disease, have heart problems, or are dehydrated
  • are 55 years of age or older
  • are on a sodium-restricted diet
  • have abdominal pain, nausea, or vomiting
  • have a sudden change in bowel habits lasting more than 2 weeks

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When Using This Product

  • do not use more than directed. Serious side effects may occur from excess dosage
  • do not use for more than 3 days, without asking a doctor

Stop Use And Ask A Doctor If

  • you have rectal bleeding
  • you have no bowel movement within 30 minutes of enema use
  • you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)

    • 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 (Or As Directed By A Doctor)

Single daily dosage (per 24 hours) Do not use if taking another sodium phosphate product. Do not use more unless directed by a doctor. See Warnings.

Adults and children 12 years of age and older1 bottle once daily
Children 2 to under 12 years of ageUse Pediatric Enema
Children under 2 years of ageDO NOT USE

Other Information

  • each 118 ml contains sodium 4.3 g
  • store at 15 to 30°C (59 to 86°F)
  • additional liquids by mouth are recommended while using this product
  • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments?

833-358-6431

Principal Display Panel - 133 Ml Bottle Carton

NDC 70677-1089-1

COMPARE TO FLEET®
SALINE ENEMA
ACTIVE INGREDIENTS*

Foster & Thrive™

READY TO USE
Enema
SALINE LAXATIVE

Lubricated Tip

Works In Minutes

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.