PURE AND GENTLE LAXATIVE- sodium phosphate enema

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR), SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR)

Available from:

Medline Industries, LP

INN (International Name):

SODIUM PHOSPHATE, DIBASIC

Composition:

SODIUM PHOSPHATE, DIBASIC 7 g in 118 mL

Administration route:

RECTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Saline laxative - relieves occasional constipation - this product generally produces bowel movement in 1 to 5 minutes

Authorization status:

OTC monograph not final

Summary of Product characteristics

PURE AND GENTLE LAXATIVE- SODIUM PHOSPHATE ENEMA
MEDLINE INDUSTRIES, LP
_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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014 PURE & GENTLE SALINE ENEMA LAXATIVE
_ACTIVE INGREDIENT_
_(IN EACH 118 ML DELIVERED DOSE)_
Dibasic sodium phosphate 7 g
Monobasic sodium phosphate 19 g
_PURPOSE_
Saline laxative
_USES_
relieves occasional constipation
this product generally produces bowel movement in 1 to 5 minutes
_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 symtoms of dehydration (thirstiness, dissiness, vomiting,
urinating less
oftan than normal)
These symptoms may indicate a serious condition.
IF PREGNANT OR BREASTFEEDING,
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.
_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.
adults & children
12 years an