Label: CVS PHARMACY- saline laxative enema
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-969-40 - Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 21, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
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Warnings
For rectal use only.
Ask a doctor or pharmacist before using if the child
- 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
- 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
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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.
children 2 to 11 years 1 bottle once daily children under 2 years ask a doctor - Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 66 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
CVS PHARMACY
saline laxative enemaProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-969 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 3.5 g in 59 mL SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 9.5 g in 59 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:59779-969-40 1 in 1 CARTON 05/20/2014 1 59 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 05/20/2014 Labeler - CVS Pharmacy (062312574) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(59779-969)