Label: SALINE ENEMA- sodium phosphate monobasic, sodium phosphate dibasic enema
- NDC Code(s): 67777-402-01
- Packager: Dynarex Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated January 30, 2014
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
( in each 118 mL delivered dose)
Dibasic sodium phosphate 7g
Monobasic sodium phosphate 19g
- Gentle relief of occasional constipation
- Gentle relief of occasional constipation
For rectal use only
Dosage Warning: Using more than one enema in 24 hours can be harmful.Close
- As a doctor before use if you have:
- a sodium-restricted diet
- abdominal pain, nausea or vomiting
- kidney disease, heart problems, or are dehydrated
- notice a sudden change in bowel habits that persists over a period of 2 weeks
- If pregnant or breast feeding, ask a health professional before use.
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.Close
- Stop use and ask a doctor if:
- If you have rectal bleeding
- you have no bowel movement after use of a laxative. This may indicate a serious condition
- Keep out of reach of children
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)Close
- Other information:
- Each 118 mL contains: Sodium 4.3 g
- Store at room temperature 15 Deg C - 30 Deg C (59 Deg F - 86 Deg F)
- This product generally produces bowel movement in 15 minutes.
Do not use more unless directed by a doctor
Adults and children 12 years and older - 1 bottle
Children 2 to under 12 years - 1/2 bottle
Children under 2 years - Do not use. Consult a physician.Close
- Inactive ingredient
- Indications and Usage
- For relief of occasional constipation
When using this product
- Do not exceed recommended dose unless directed by a doctor. Serious side effects may occur from excess dosage.
- Do not use more than three days.
Use of this product:
CAUTION: REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING
Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.
Left-side position: Lie on left side with knees bent and arms at rest. (see diagram on box)
Knee-chest position: Kneel, then lower headand chest forward until left side of face is resting on surface. Position arms comfortably. (see diagram on box)
- With steady pressure, gently insert enema with tip pointing toward navel.
- Squeeze bottle until recommended dose is expelled ( it is not necessary to empty unit completely. Bottle contains more liquid than needed for effective use. A small amount of liquid will remain in bottle after squeezing).
- Remove tip from rectum.
- Stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.
- Maintain position until urge to evacuate is strong (usually 1 to 5 minutes).
- If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.
- Principal Display Panel
- INGREDIENTS AND APPEARANCE
sodium phosphate monobasic, sodium phosphate dibasic enema
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-402 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC 7 g in 118 mL SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC 19 g in 118 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-402-01 1 in 1 BOX 1 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 08/29/2012 Labeler - Dynarex Corporation (008124539) Registrant - Dynarex Corporation (008124539)