Oral Saline Laxative

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Full prescribing information#

Active ingredient (in each tablespoon)

OTC - ACTIVE INGREDIENT SECTION

Dibasic sodium phosphate 2.7 g

Monobasic sodium phosphate 7.2 g

Purpose

OTC - PURPOSE SECTION

Saline laxative

Use

INDICATIONS & USAGE SECTION

• for relief of occasional constipation

Warnings

WARNINGS SECTION

Dosage warning

Taking more than the recommended dose in 24 hours can be harmful.

Do not use

OTC - DO NOT USE SECTION

• if you have a previous kidney problem, congestive heart failure, impaired renal functions, decreased intervascular volume, dehydration, uncorrected electrolyte abnormalities
• in children under 5 years of age
• for bowel cleansing

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• abdominal pain, nausea, or vomiting
• kidney disease
• heart problems
• a sudden change in bowel habits lasting more than 2 weeks
• already used a laxative for more than a week
• a dehydration condition

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

• on a sodium restricted diet
• under a doctor’s care for any medical condition
• taking any other prescription or non-prescription medications. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if you

OTC - STOP USE SECTION

• have any rectal bleeding
• do not have a bowel movement within 6 hours
• have any symptoms that your body is losing more fluid than you are drinking
• have early symptoms of dehydration including feeling thirsty, dizziness, urinating less often than normal, vomiting.
• These symptoms may indicate a serious condition.

If pregnant or breast feeding, ask a health professional before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center immediately. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

• use as a laxative for relief of occasional constipation
• dilute dose in the table below with one glass (8 fl. oz.) cool water. Drink, then follow with at least one additional glass (8 fl. oz.) cool water. There is significant loss of liquid when using this product. To prevent dehydration drink plenty of clear liquid after use.
• Do not use for bowel cleansing.
• Do not take more unless directed by a doctor. See Warning. There are three Teaspoons in one Tablespoon.

Ages (Years)	Dosage	Maximum Dose
12 & Older	3 Teaspoons	6 or 9 Teaspoons*
10 & 11	3 Teaspoons*	3 Teaspoons*
5 to 9	1 1/2 Teaspoons*	1 1/2 Teaspoons*
under 5	Do Not Use	Do Not Use

• *SINGLE DAILY DOSAGE. DO NOT TAKE MORE OF THIS PRODUCT IN A 24-HOUR PERIOD

Other information

STORAGE AND HANDLING SECTION

• Each Teaspoon contains: sodium 556 mg
• Saline laxatives increase retention of water in the intestine, promoting bowel movements.
• this product generally produces a bowel movement in 30 minutes to 6 hours
• this product is sugar free
• do not freeze
• store at room temperature

TAMPER EVIDENT: Mouth of bottle sealed for your safety. If foil seal is missing or broken, do not use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ginger lemon flavor, glycerin, purified water, saccharin sodium, sodium benzoate

Questions

OTC - QUESTIONS SECTION

1-800-633-5463

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49738-111-12

Smart Sense

ORAL SALINE LAXATIVE

GINGER LEMON FLAVOR

For relief of occasional constipation

Sugar Free

1.5 FL OZ (45 mL)

Package Drug Facts 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Drug Facts 2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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• Oral Saline Laxative Ginger Lemon
• dibasic sodium phosphate, monobasic sodium phosphate
• SODIUM PHOSPHATE, DIBASIC
• PHOSPHATE ION
• SODIUM PHOSPHATE, MONOBASIC
• GLYCERIN
• WATER
• SACCHARIN SODIUM
• SODIUM BENZOATE

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