![QUALITY CHOICE SINGLE SALINE LAXATIVE (SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) ENEMA [ALCYON HEALTH, LLC.]](https://medic.hrt.org//dailymed/images/eb499c7f-9c7b-4097-83a3-82aabffd6beb/quality-01.jpg)
| NDC | 71443-001-06 |
| Set ID | eb499c7f-9c7b-4097-83a3-82aabffd6beb |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Alcyon Health, LLC. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART334 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
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Warnings
For rectal use only
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.
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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 - Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE SINGLE SALINE LAXATIVE
sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enemaProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71443-001 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 7 g in 118 mL SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 19 g in 118 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71443-001-06 6 in 1 CARTON 07/05/2017 1 133 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 07/05/2017 Labeler - Alcyon Health, LLC. (080040408) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(71443-001)
