PEDIA-LAX- sodium phosphate, dibasic and sodium phosphate, monobasic enema

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37), sodium phosphate, monobasic (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR)

Available from:

C.B. Fleet Company, Inc.

INN (International Name):

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

Composition:

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 3.5 g in 66 mL

Administration route:

RECTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Saline laxative Saline laxative for relief of occasional constipation.

Authorization status:

OTC monograph not final

Summary of Product characteristics

PEDIA-LAX- SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE,
MONOBASIC ENEMA
C.B. FLEET COMPANY, INC.
_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._
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PEDIA-LAX ENEMA SALINE LAXATIVE 0132-0202
PEDIA-LAX SODIUM PHOSPHATES SALINE ENEMA
C.B. FLEET COMPANY, INC.
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DRUG FACTS
ACTIVE INGREDIENTS
(in each 59-mL delivered dose)
Monobasic Sodium Phosphate 9.5 g................
Dibasic Sodium Phosphate 3.5 g........................
PURPOSE
Saline laxative
Saline laxative
USE
for relief of occasional constipation.
WARNINGS
For rectal use only.
DOSAGE WARNING:
USING MORE THAN ONE ENEMA IN 24 HOURS CAN BE HARMFUL.
DO NOT USE WITHOUT ASKING A DOCTOR:
for more than 3 days
if your child has a kidney disease
if your child has heart problems
if your child is dehydrated
ASK A DOCTOR BEFORE USING THIS PRODUCT IF THE CHILD
is on a sodium-restricted diet
ASK A DOCTOR BEFORE USING ANY LAXATIVE IF YOUR CHILD HAS
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
STOP USE AND ASK A DOCTOR IF YOUR CHILD HAS
rectal bleeding
no bowel movement or no liquid comes out of the child’s rectum after
30 minutes
symptoms of dehydration [feeling thirsty, dizziness, vomiting,
urinating less often
than normal]
These symptoms may indicate a serious condition.
KEEP OUT OF REACH OF CHILDREN TO PREVENT ACCIDENTAL INGESTION.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
Single Daily Dosage (per 24 hours)
DO NOT USE MORE PER DAY UNLESS DIRECTED BY A DOCTOR. SEE WARNINGS.
Do not use if child is taking another sodium phosphates product.
Age
Dose
children 5 to 11 years
1 bottle per day or as directed by doctor
children 2 to under 5 years
one-half bottle per day (see below)
children under 2 years
DO NOT USE
ONE-HALF BOTTLE PREPARATION:
Unscrew cap and remo