Pro-Enema Single Saline Laxative

Pro-Enema Single Saline Laxative is an FDA-registered drug product whose active ingredient is SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM. It is labelled by Propharma Medical Supplies taken by rectal and marketed as a human otc drug product. Identifiers on file: NDC 71451-001, application part334, label effective 20170608. It is one of 2 FDA drug label records sharing the active ingredient SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM are most often described in connection with: relieves occasional. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use Relieves occasional constipation

Directions 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 old and older 1 bottle once daily Children 2 to under 12 years old 1/2 bottle once daily Children under 2 years DO NOT USE

Warnings Dosage warning Using more than one enema in 24 hours can be harmful. For rectal use only. Ask a doctor before use if you already used a laxative for more than 1 week have kidney disease have heart problems are dehydrated are 55 years old or older are on a sodium-restricted diet 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 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 bleeding the condtion worsens or does not improve within 7 days 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. 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:

FDA lists 2 drug label records with SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Pro-Enema Single Saline Laxative used for?
Use Relieves occasional constipation

Who makes Pro-Enema Single Saline Laxative?
Propharma Medical Supplies is the labeler of record for Pro-Enema Single Saline Laxative. 2 FDA label records share the active ingredient SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Pro-Enema Single Saline Laxative come in?
administered by rectal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Pro-Enema Single Saline Laxative prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM?
Yes. 2 FDA drug label records list SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Pro-Enema Single Saline Laxative been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.