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  5. Label Information: Smooth Texture Orange Flavor

FDA Label for Smooth Texture Orange Flavor

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (PER EACH ROUNDED TABLESPOON=12 G)
    2. PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. FIBER SUPPLEMENT INFORMATION
    14. PDP

Smooth Texture Orange Flavor Product Label

The following document was submitted to the FDA by the labeler of this product Mckesson. 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 (Per Each Rounded Tablespoon=12 G)



Psyllium husk 3.4 g


Purpose



Bulk-forming laxative


Otc - Keep Out Of Reach Of Children





Uses



  • effective in treating occasional constipation and restoring regularity

Warnings



Allergy alert: May cause allergic reaction in people sensitive to ingested or inhaled psyllium

Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.


Ask A Doctor Before Use If You Have



  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits persisting for 2 weeks

Ask A Doctor Or Pharmacist Before Use If You Are



taking any other drug. Laxatives may affect how other drugs work.


When Using This Product



  • do not exceed the maximum recommended daily dosage in a 24-hour period
  • you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake

Stop Use And Ask A Doctor If



  • constipation lasts more than 7 days
  • rectal bleeding occurs
    • These could be signs of a serious  condition.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions



  • take at the first sign of irregularity up to 3 times a day
  • put one dose into an empty glass
  • fill glass with 8oz of water or favorite beverage
  • stir briskly and drink promptly
  • if mixture thickens add more water and stir
  • take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
  • if you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine.
    • New Users: Start with 1 dose per day; gradually increase to 3 doses per day as necessary

    adults and children 12 years and over
    		1 rounded tablespoon                         
    6 to under 12 years
    		1/2 tablespoon
    under 6 years
    		ask a doctor


Other Information



  • each tablespoon contains: potassium 30 mg and sodium 5 mg
  • store at (20o-25oC) 68o-77oF

Inactive Ingredients



citric acid, FD and C yellow 6, natural and artificial flavor, silicon dioxide, sucrose

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR BROKEN


Fiber Supplement Information



Uses Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium seed husk, may reduce the risk of heart disease by lowering cholesterol levels. One ADULT serving provides 2.4 grams of this soluble fiber. Consult a doctor if you are considering use of the product as part of a cholesterol-lowering program.

Warnings Read entire label, including warnings in Drug Facts

Directions Adults 12 years and older: 1 rounded TABLESPOON (tbsp) in 8 oz  of liquid 3 times daily.

Children under 12 years:  Consult a doctor.

NOTICE: Mix this product with at least 8 ounces (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take  if you have difficulty swallowing.  See choking warning.


Pdp



Sunmark

compare to the active ingredient in Metamucil®

fiber

Smooth Texture

Bulk-forming laxative

Dietary fiber supplement

100% Natural Psyllium Seed Husk Fiber

Orange Flavor

Naturally and Artificially Flavored

48 Tablespoon doses

Net wt 20.3 oz (575 g) (1 LB 4.3 OZ)

FILL CONTROLLED BY WEIGHT, NOT VOLUME

smooth texture orange flavor - SM403

smooth texture orange flavor - SM403



* Please review the disclaimer below.