4719 Enema, Saline Ndc 67777-402-01

4719 Enema, Saline Ndc 67777-402-01
SPL v9
SPL
SPL Set ID 7c7b68af-4ef2-4f84-9279-9f7a91c8d9c5
Route
RECTAL
Published
Effective Date 2013-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phosphate Ion (7 g)
Inactive Ingredients
Benzalkonium Chloride Water Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-08-29

Description

( in each 118 mL delivered dose) Dibasic Sodium Phosphate 7g Monobasic Sodium Phosphate 19g

Purpose

Saline Laxative


Medication Information

Purpose

Saline Laxative

Description

( in each 118 mL delivered dose) Dibasic Sodium Phosphate 7g Monobasic Sodium Phosphate 19g

Uses

• For relief of occasional constipation

• This product generally produces bowel movement in 2 to 15 minutes

Label

4719 Enema Saline Laxative

Warnings:

For rectal use only

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

Directions

Adults and children 12 years old and over - 1 bottle once daily

Children 2 to under 12 years of age - 1/2 bottle once daily, discard unused portion

Children under 2 years - Consult a physician.

Do Not Use

• Laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

• Longer than 1 week unless directed by a doctor

• This product if you are on a low salt diet unless directed by a doctor

• This product if you have kidney disease unless directed by a doctor

Questions?

1-888-DYNAREX Monday - Friday 9AM - 5PM EST

Active Ingredients

( in each 118 mL delivered dose)

Dibasic Sodium Phosphate 7g

Monobasic Sodium Phosphate 19g

Other Information:
  • Sodium content in each dose (1 bottle): 4.4 g
  • Store at room temperature 15º-30ºC (59º- 8ºF)
Inactive Ingredients

Benzalkonium Chloride, Disodium EDTA, Purified Water

Keep Out of Reach of Children

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

Stop Use and Ask A Doctor If:
  • If you have rectal bleeding or fail to have a bowel movement after use
Ask A Doctor Before Use If You Have:

Noticed a sudden change in bowel habits that persists over a period of 2 weeks


Structured Label Content

Uses

• For relief of occasional constipation

• This product generally produces bowel movement in 2 to 15 minutes

Label

4719 Enema Saline Laxative

Purpose

Saline Laxative

Warnings:

For rectal use only

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

Directions

Adults and children 12 years old and over - 1 bottle once daily

Children 2 to under 12 years of age - 1/2 bottle once daily, discard unused portion

Children under 2 years - Consult a physician.

Do Not Use (Do not use)

• Laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

• Longer than 1 week unless directed by a doctor

• This product if you are on a low salt diet unless directed by a doctor

• This product if you have kidney disease unless directed by a doctor

Questions?

1-888-DYNAREX Monday - Friday 9AM - 5PM EST

Active Ingredients

( in each 118 mL delivered dose)

Dibasic Sodium Phosphate 7g

Monobasic Sodium Phosphate 19g

Other Information: (Other information:)
  • Sodium content in each dose (1 bottle): 4.4 g
  • Store at room temperature 15º-30ºC (59º- 8ºF)
Inactive Ingredients (Inactive ingredients)

Benzalkonium Chloride, Disodium EDTA, Purified Water

Keep Out of Reach of Children (Keep out of reach of children)

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

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • If you have rectal bleeding or fail to have a bowel movement after use
Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)

Noticed a sudden change in bowel habits that persists over a period of 2 weeks


Advanced Ingredient Data


Raw Label Data

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