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| Product NDC Code | 69626-0084 | ||||
|---|---|---|---|---|---|
| Drug Name | Relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | RECTAL | ||||
| Dosage Form | ENEMA | ||||
| Application Number | part334 | ||||
| Labeler Name | Leosons Overseas Corp | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients & Purpose Active ingredients (in each 118 mL delivered dose) Purpose Monobasic Sodium Phosphate 19 g............................................... Saline laxative Dibasic Sodium Phosphate 7 g....................................................... Saline laxative
| Monobasic Sodium Phosphate 19 g............................................... | Saline laxative |
| Dibasic Sodium Phosphate 7 g....................................................... | Saline 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 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
| Adults and Children 12 years and over | 1 Bottle |
| Children 2 to under 12 years | 1/2 Bottle once daily |
| Children under 2 years |
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 for relief of occasional constipation
Purpose
Information about the drug product’s indications for use.Active ingredients (in each 118 mL delivered dose) Purpose Monobasic Sodium Phosphate 19 g............................................... Saline laxative Dibasic Sodium Phosphate 7 g....................................................... Saline laxative
| Monobasic Sodium Phosphate 19 g............................................... | Saline laxative |
| Dibasic Sodium Phosphate 7 g....................................................... | Saline laxative |
Spl product data elements
Usually a list of ingredients in a drug product.Relief SODIUM PHOSPHATE, MONOBASIC and SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE BENZALKONIUM CHLORIDE EDETATE DISODIUM WATER SODIUM PHOSPHATE, MONOBASIC PHOSPHATE ION SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE PHOSPHATE ION
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 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) 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 Drug Facts
Distributed by: Leosons 10 Maryland Avenue Albany, New York 12205
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 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
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
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call toll-free at +1-855-452-9500 or email [email protected]
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 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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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 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.
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 For rectal use only Dosage Warning: Using more than one enema in 24 hours can be harmful. 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 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 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. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me 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