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  5. Label Information: Oral Saline Laxative Ginger Lemon

FDA Label for Oral Saline Laxative Ginger Lemon

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLESPOON)
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. STOP USE AND ASK A DOCTOR IF YOU
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS
    14. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Oral Saline Laxative Ginger Lemon Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablespoon)



Dibasic sodium phosphate 2.7 g

Monobasic sodium phosphate 7.2 g


Purpose



Saline laxative


Use



  • •for relief of occasional constipation

Warnings



Dosage warning

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


Do Not Use



  • •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



  • •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



  • •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



  • •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.

Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center immediately.


Directions



  • •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



  • •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



Cherry flavor, glycerin, purified water, saccharin sodium, sodium benzoate


Questions



1-800-633-5463


Package/Label Principal Display Panel



FOR DIRECTIONS LIFT SIDE PANEL

CVS Health

NDC 59779-111-12

Phosphate

Oral Saline Laxative

For relief of occasional constipation

GINGER LEMON FLAVOR

1.5 fl oz (45 mL)


* Please review the disclaimer below.