QUALITY CHOICE SINGLE SALINE LAXATIVE- sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37), SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)

Available from:

CDMA

INN (International Name):

SODIUM PHOSPHATE, DIBASIC

Composition:

SODIUM PHOSPHATE, DIBASIC 7 g in 118 mL

Administration route:

RECTAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

QUALITY CHOICE SINGLE SALINE LAXATIVE- SODIUM PHOSPHATE, DIBASIC AND
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM ENEMA
CDMA
_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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QUALITY CHOICE SINGLE SALINE ENEMA
LAXATIVE
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH_
_118ML DELIVERED DOSE)_
_PURPOSE_
Dibasic Sodium Phosphate 7 g
Saline laxative
Monobasic Sodium Phosphate 19
g
Saline laxative
USE
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 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: 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 US