NDC | 63868-380-45, 63868-380-90 |
Set ID | 64950e20-91a8-4914-81aa-850f1a027ca6 |
Category | HUMAN OTC DRUG LABEL |
Packager | CDMA |
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
- 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.
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Directions
Single daily dosage (per 24 hours)
Do not use more unless directed by a doctor. See Warnings.Do not use if taking another sodium phosphate product.
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
-
INGREDIENTS AND APPEARANCE
QUALITY CHOICE SINGLE SALINE LAXATIVE
sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enemaProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-380 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC 7 g in 118 mL SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) 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:63868-380-45 1 in 1 CARTON 06/01/2010 1 133 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:63868-380-90 2 in 1 CARTON 06/01/2010 2 133 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 06/01/2010 Labeler - CDMA (011920774) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(63868-380)