QUALITY CHOICE SINGLE SALINE LAXATIVE

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM RECTAL HUMAN OTC DRUG

QUALITY CHOICE SINGLE SALINE LAXATIVE is an FDA drug label for the active ingredient SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM manufactured by Alcyon Health, LLC. administered by RECTAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20170712.

Generic name
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Manufacturer
Alcyon Health, LLC.
Product type
HUMAN OTC DRUG
Route
RECTAL
Dosage form
N/A
NDC
71443-001
Application
part334
Label effective
20170712

About this product

QUALITY CHOICE SINGLE SALINE LAXATIVE is an FDA-registered drug product whose active ingredient is SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM. It is labelled by Alcyon Health, LLC. taken by rectal and marketed as a human otc drug product. Identifiers on file: NDC 71443-001, application part334, label effective 20170712. It is one of 3 FDA drug label records sharing the active ingredient SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 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.

What it is used for

Across FDA labelling, products containing SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 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.

Active ingredients

Active ingredients (in each 118 mL delivered dose) Purpose Dibasic Sodium Phosphate 7 g Saline laxative Monobasic Sodium Phosphate 19 g Saline laxative

Indications & Usage

Use Relieves occasional constipation

Dosage & Administration

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

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 already used a laxative for more than 1 week are dehydrated have kidney disease are 55 years old or older have heart problems 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 condition 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.

More products with the same ingredient

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM

FREDS SALINE TWIN PACK LAXATIVE

FRED'S View label

Marcs Twin Pack

Marc Glassman Inc. View label

How products containing SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM compare

FDA lists 3 drug label records with SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 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.

Dosage formProductsManufacturerProducts
— — Alcyon Health, LLC. 1
— — FRED'S 1
— — Marc Glassman Inc. 1
— — — —
— — — —

Frequently asked questions

What is QUALITY CHOICE SINGLE SALINE LAXATIVE used for?
Use Relieves occasional constipation

Who makes QUALITY CHOICE SINGLE SALINE LAXATIVE?
Alcyon Health, LLC. is the labeler of record for QUALITY CHOICE SINGLE SALINE LAXATIVE. 3 FDA label records share the active ingredient SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 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 QUALITY CHOICE 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 QUALITY CHOICE 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, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM?
Yes. 3 FDA drug label records list SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 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 QUALITY CHOICE 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.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.