Relief Pediatric Enema (natureplex)

Relief Pediatric Enema (natureplex)
SPL v3
SPL
SPL Set ID 90e7c2b4-35e1-4a27-afea-9257c480e190
Route
RECTAL
Published
Effective Date 2019-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (3.5 g)
Inactive Ingredients
Benzalkonium Chloride Edetate Disodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • relieves occasional constipation
  • this product generally produces bowel movement in 1 to 5 minutes
Section 55105-1
Active ingredients (in each 59 ml delivered dose) Purpose
Dibasic Sodium Phosphate 3.5g..... Saline laxative
Monobasic Sodium Phosphate 9.5g..... Saline laxative
Warnings

For rectal use only.

Do Not Use
  • on children under 2 years of age
Drug Facts

Drug Facts

Distributed By:



Leosons

10 Maryland Avenue

Albany, New York 12205

Dosage Warning:

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

Other Information
  • each 59 mL contains 2.2g sodium
  • 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?

Call toll-free at +1-855-452-9500 or email [email protected]

Principal Display Panel

NDC 69626-0085-7

RELIEF

SALINE LAXATIVE

Pediatric

Ready-to-Use

ENEMA

For relief of occasional constipation

  • Pre-Mixed
  • Not Made With Natural Rubber Latex

Ages 2-11

Lubricated Tip

2.25 FL OZ (67 mL)

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
Keep Out of Reach of Children.

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

Ask A Doctor Before Use If the Child
  • has already used a laxative for more than 3 days
  • has kidney disease, have heart problems, or are dehydrated
  • is on a sodium-restricted diet
  • has abdominal pain, nausea, or vomiting
  • has a sudden change in bowel habits lasting more than 2 weeks
Stop Use and Ask A Doctor If the Child
  • has rectal bleeding
  • has no bowel movement within 30 minutes of enema use
  • has symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal). These symptoms may indicate a serious condition.
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.
children 2 to under 12 years of age Use 1 bottle once daily
children under 2 years of age DO NOT USE
Ask A Doctor Or Pharmacist Before Use If

the child is taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.


Structured Label Content

Uses
  • relieves occasional constipation
  • this product generally produces bowel movement in 1 to 5 minutes
Section 55105-1 (55105-1)
Active ingredients (in each 59 ml delivered dose) Purpose
Dibasic Sodium Phosphate 3.5g..... Saline laxative
Monobasic Sodium Phosphate 9.5g..... Saline laxative
Warnings

For rectal use only.

Do Not Use (Do not use)
  • on children under 2 years of age
Drug Facts

Drug Facts

Distributed By: (Distributed by:)



Leosons

10 Maryland Avenue

Albany, New York 12205

Dosage Warning: (Dosage warning:)

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

Other Information (Other information)
  • each 59 mL contains 2.2g sodium
  • 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 (Inactive ingredients)

benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments? (Questions or comments?)

Call toll-free at +1-855-452-9500 or email [email protected]

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 69626-0085-7

RELIEF

SALINE LAXATIVE

Pediatric

Ready-to-Use

ENEMA

For relief of occasional constipation

  • Pre-Mixed
  • Not Made With Natural Rubber Latex

Ages 2-11

Lubricated Tip

2.25 FL OZ (67 mL)

When Using This Product (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
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.

Ask A Doctor Before Use If the Child (Ask a doctor before use if the child)
  • has already used a laxative for more than 3 days
  • has kidney disease, have heart problems, or are dehydrated
  • is on a sodium-restricted diet
  • has abdominal pain, nausea, or vomiting
  • has a sudden change in bowel habits lasting more than 2 weeks
Stop Use and Ask A Doctor If the Child (Stop use and ask a doctor if the child)
  • has rectal bleeding
  • has no bowel movement within 30 minutes of enema use
  • has symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal). These symptoms may indicate a serious condition.
Directions (or As Directed By A Doctor) (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.
children 2 to under 12 years of age Use 1 bottle once daily
children under 2 years of age DO NOT USE
Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

the child is taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.


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