Up And Up Ready To Use Enema
FDA Label NDC 11673-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Up And Up Ready To Use Enema (NDC 11673-002). 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 active ingredients (in each 118 ml delivered dose), purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients (In Each 118 Ml Delivered Dose)

Dibasic sodium phosphate 7 g

Monobasic sodium phosphate 19 g

Purpose

Saline laxative

Uses

  • relieves occasional constipation

Warnings

For rectal use only

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

Ask A Doctor Before Use If You Have

  • a sodium-restricted diet
  • abdominal pain, nausea or vomiting
  • kidney disease, heart problems, or are dehydrated
  • noticed a sudden change in bowel habits that lasts over 2 weeks

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

Stop Use And Ask A Doctor If

  • you have rectal bleeding
  • you have no bowel movement after use of a laxative
  • These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

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

adults & children 12 years and over

one bottle once daily

children 2 to under 12 years

½ bottle once daily

children under 2 years

do not use

Caution:

REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING; HOLD BOTTLE UPRIGHT, GRASPING BOTTLE CAP WITH FINGERS. GRASP PROTECTIVE SHIELD WITH OTHER HAND AND PULL GENTLY TO REMOVE.

Directions For Use Of Enema (Hand Insertion)

Directions For Use Of Enema (Hand Insertion)

Positioning:

Left-side position: Lie on left side with knee bent and arms at rest.

Directions For Use Of Enema (left side positioning)

Directions For Use Of Enema (left side positioning)

Knee-chest position:

Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.

Directions For Use Of Enema (Knee Chest Positing)

Directions For Use Of Enema (Knee Chest Positing)

Administering enema:

  •  With steady pressure, gently insert enema with tip pointing toward navel
  • squeeze bottle until recommended dose is expelled (it is not necessary to empty until completely. Bottle contains more liquid than needed for effective use. A small amount of liquid will remain in bottle after squeezing).
  • Remove tip from rectum.
  • stop using if tip is hard to insert. Forcing the tip into rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.
  • maintain position until urge to evacuate is strong (usually 1 to 5 minutes)
  • if no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.

Other Information

  • each 118 mL contains: sodium 4.3 g
  • store at room temperature 20°-25°C (68°-77°F)
  • this product generally produces bowel movement in 1 to 5 minutes

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments?

1-800-910-6874

Principal Display Panel

ready-to-use enema

saline laxative

Compare to active ingredients of Fleet® Enema Saline

for relief of occasional constipation

comfortable, lubricated tip

works in minutes

latex free

2 Units

Principal Display Panel (A58653e1 4e87 40b9 8b8e 341a28cc4fe4 04)

Principal Display Panel (A58653e1 4e87 40b9 8b8e 341a28cc4fe4 04)

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