Sodium Phosphate, Dibasic and Sodium Phosphate, Monobasic, Unspecified Form

FDA Drug Profile — Sunmark Saline Single Laxative, Saline Laxative Cherry Laxative, Leader Ready to Use Saline Laxative, HealthMart Saline Single Laxative

Drug Details

Generic Name
Sodium Phosphate, Dibasic and Sodium Phosphate, Monobasic, Unspecified Form
Brand Names
Sunmark Saline Single Laxative, Saline Laxative Cherry Laxative, Leader Ready to Use Saline Laxative, HealthMart Saline Single Laxative
Application Number
M007
Sponsor
Strategic Sourcing Services LLC
NDC Codes
4
Dosage Forms
ENEMA, LIQUID
Routes
RECTAL, ORAL
Active Ingredients
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM, SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM, SODIUM PHOSPHATE, DIBASIC

Indications and Usage

Use relieves occasional constipation this product generally produces bowel movement in 1 to 5 minutes

Warnings

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: 1-800-222-1222.