Label: SALINE ENEMA enema
Contains inactivated NDC Code(s)
NDC Code(s): 61767-002-01
- Packager: Blossom Pharmaceuticals
- 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.
Drug Label Information
Updated January 30, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- As a doctor before use if you have:
- Indications & Usage
- Keep out of reach of children
- Other information:
Dosage & Administration
Single daily dose
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.
How to use this enema:
REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING.
Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with the other hand and pull gently to remove.
See image on box
Left-side position: Lie on left side with knee bent and arms at rest.
See image on box
Knee-chest position: Kneel, then lower head and chest forward until the left side of face is resting on surface. Position arms comfortably.
See image 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 immediatemedical 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.
- INACTIVE INGREDIENT
- Principal Display Panel
INGREDIENTS AND APPEARANCE
saline enema enema
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61767-002 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:61767-002-01 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 02/01/2014 Labeler - Blossom Pharmaceuticals (677381470) Establishment Name Address ID/FEI Business Operations Blossom Pharmaceuticals 677381470 manufacture(61767-002)