Relief Saline Laxative 4.5 Fl Oz

Relief Saline Laxative 4.5 Fl Oz
SPL v4
SPL
SPL Set ID 5b301d5b-1e2c-47ed-a05f-d6be0fdfc940
Route
RECTAL
Published
Effective Date 2015-02-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phosphate Ion (19 g)
Inactive Ingredients
Benzalkonium Chloride Edetate Disodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-02-09

Description

Drug Facts


Medication Information

Description

Drug Facts

Use

for relief of occasional constipation

Section 55105-1
Active ingredients (in each 118 mL delivered dose) Purpose
Monobasic Sodium Phosphate 19 g............................................... Saline laxative
Dibasic Sodium Phosphate 7 g....................................................... Saline laxative
Warnings

For rectal use only

Directions
  • Single daily dosage.
  • Do not use more unless directed by a doctor. See Warnings.
  • Do not use if taking another sodium phosphates product.
Adults and Children 12 years and over 1 Bottle
Children 2 to under 12 years 1/2 Bottle once daily
Children under 2 years DO NOT USE
Drug Facts

Drug Facts

Questions?

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

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 118 mL delivered dose contains: sodium 4.4 g
  • additional liquids by mouth are recommended while using this product
  • this product generally produces a bowel movement in 1-5 minutes
  • store between 15°- 30°C (59°- 86°F)
  • carton sealed for safety. Do not use if top or bottom flap of carton is torn or missing.
  • consult PHYSICIANS' DESK REFERENCE® for complete professional labeling.
Inactive Ingredients

Benzalkonium chloride, disodium EDTA, purified water

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.

Stop Use and Ask A Doctor If You Have
  • rectal bleeding
  • no bowel movement within 30 minutes of enema use
  • symptoms of dehydration (feeling thirsty, dizziness, vomiting, urinating less often than normal)

These symptoms may indicate a serious condition.

Ask A Doctor Before Using This Product If You
  • are on a sodium-restricted diet
  • have kidney disease
  • are 65 or older and under a doctor's care for any medical condition
Principal Display Panel 133 Ml Bottle Carton

RELIEF

SALINE LAXATIVE

Ready-to-Use

ENEMA

For relief of

occasional

constipation

  • Pre-Mixed
  • Latex Free

Lubricated Tip

1 Bottle 4.5 FL OZ (133mL)

Ask A Doctor Before Using Any Laxative If You Have
  • abdominal pain, nausea, or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

Structured Label Content

Use

for relief of occasional constipation

Section 55105-1 (55105-1)
Active ingredients (in each 118 mL delivered dose) Purpose
Monobasic Sodium Phosphate 19 g............................................... Saline laxative
Dibasic Sodium Phosphate 7 g....................................................... Saline laxative
Warnings

For rectal use only

Directions
  • Single daily dosage.
  • Do not use more unless directed by a doctor. See Warnings.
  • Do not use if taking another sodium phosphates product.
Adults and Children 12 years and over 1 Bottle
Children 2 to under 12 years 1/2 Bottle once daily
Children under 2 years DO NOT USE
Drug Facts

Drug Facts

Questions?

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

Distributed By: (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 (Other information)
  • each 118 mL delivered dose contains: sodium 4.4 g
  • additional liquids by mouth are recommended while using this product
  • this product generally produces a bowel movement in 1-5 minutes
  • store between 15°- 30°C (59°- 86°F)
  • carton sealed for safety. Do not use if top or bottom flap of carton is torn or missing.
  • consult PHYSICIANS' DESK REFERENCE® for complete professional labeling.
Inactive Ingredients (Inactive ingredients)

Benzalkonium chloride, disodium EDTA, purified water

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

Stop Use and Ask A Doctor If You Have (Stop use and ask a doctor if you have)
  • rectal bleeding
  • no bowel movement within 30 minutes of enema use
  • symptoms of dehydration (feeling thirsty, dizziness, vomiting, urinating less often than normal)

These symptoms may indicate a serious condition.

Ask A Doctor Before Using This Product If You (Ask a doctor before using this product if you)
  • are on a sodium-restricted diet
  • have kidney disease
  • are 65 or older and under a doctor's care for any medical condition
Principal Display Panel 133 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton)

RELIEF

SALINE LAXATIVE

Ready-to-Use

ENEMA

For relief of

occasional

constipation

  • Pre-Mixed
  • Latex Free

Lubricated Tip

1 Bottle 4.5 FL OZ (133mL)

Ask A Doctor Before Using Any Laxative If You Have (Ask a doctor before using any laxative if you have)
  • abdominal pain, nausea, or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

Advanced Ingredient Data


Raw Label Data

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