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Saline laxative - Prescription Drug Labeling

Product NDC Code 0904-6320
Drug Name

Saline laxative

Type Generic
Active Ingredients
Sodium phosphate, dibasic, unspecified form 7 g/133ml
Sodium phosphate, monobasic, unspecified form 19 g/133ml
Route RECTAL
Dosage Form ENEMA
RxCUI drug identifier 283100
Application Number part334
Labeler Name Major Pharmaceuticals
Packages
Package NDC Code Description
0904-6320-78 133 ml in 1 bottle (0904-6320-78)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients (in each 118mL delivered dose) Purpose Dibasic Sodium Phosphate 7 g Saline laxative Monobasic Sodium Phosphate 19 g Saline laxative
Active ingredients (in each 118mL delivered dose) Purpose
Dibasic Sodium Phosphate 7 gSaline laxative
Monobasic Sodium Phosphate 19 gSaline laxative

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 . Adults and children 12 years of age and older 1 bottle once daily Children 2 to under 12 years of age Use Pediatric Enema Children under 2 years of age DO NOT USE
Adults and children 12 years of age and older1 bottle once daily
Children 2 to under 12 years of ageUse Pediatric Enema
Children under 2 years of ageDO NOT USE

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients benzalkonium chloride, disodium EDTA, purified water

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use relieves occasional constipation this product generally produces bowel movement in 1 to 5 minutes

Purpose

Information about the drug product’s indications for use.
Active ingredients (in each 118mL delivered dose) Purpose Dibasic Sodium Phosphate 7 g Saline laxative Monobasic Sodium Phosphate 19 g Saline laxative
Active ingredients (in each 118mL delivered dose) Purpose
Dibasic Sodium Phosphate 7 gSaline laxative
Monobasic Sodium Phosphate 19 gSaline laxative

Spl product data elements

Usually a list of ingredients in a drug product.
Saline Laxative Saline Laxative SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM PHOSPHATE ION SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM PHOSPHATE ION BENZALKONIUM CHLORIDE EDETATE DISODIUM WATER

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton MAJOR ® NDC 0904-6320-78 Compare to the active ingredients of Fleet ® Saline Enema* Ready-to-Use Enema Saline Laxative For relief of occasional constipation Not made with natural rubber latex 4.5 FL OZ (133 mL) 1 Bottle PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Distributed by: MAJOR ® PHARMACEUTICALS Livonia, MI 48152

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have already used a laxative for more than 3 days have kidney disease, have heart problems, or are dehydrated are 55 years of age or older are on a sodium-restricted diet have abdominal pain, nausea, or vomiting have a sudden change in bowel habits lasting more than 2 weeks

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on children under 2 years of age

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? (800) 616-2471

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if you have rectal bleeding 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.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug 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

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information each 118 ml contains sodium 4.3 g 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.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings Dosage warning Using more than one enema in 24 hours can be harmful. For rectal use only. Do not use on children under 2 years of age Ask a doctor before use if you have already used a laxative for more than 3 days have kidney disease, have heart problems, or are dehydrated are 55 years of age or older are on a sodium-restricted diet have abdominal pain, nausea, or vomiting have a sudden change in bowel habits lasting more than 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. 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 Stop use and ask a doctor if you have rectal bleeding 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: 800-222-1222.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API