SUNMARK FIBER SMOOTH TEXTURE- psyllium husk powder, for suspension

Sunmark fiber Smooth Texture by

Drug Labeling and Warnings

Sunmark fiber Smooth Texture by is a Otc medication manufactured, distributed, or labeled by McKesson. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (per each rounded teaspoon=5.8 g)

psyllium husk 3.4 g

Purpose

Bulk-forming laxative

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 teaspoon
• 6 to under 12 years: 1/2 teaspoon
• under 6 years: ask a doctor

Other information

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

Inactive ingredients

aspartame, citric acid, FD and C yellow 6, maltodextrin, natural and artificial orange flavor, silicon dioxide.

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

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 soluble fiber. Consult a doctor if you are considering use of the products as part of a cholesterol-lowering program.

Warnings Read entire label, including warnings in Drug Facts

Directions Adults 12 years and older: 1 rounded TEASPOON (tsp) 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 havbe difficulty swallowing.  See choking warning.

PDP

Sunmark

Compare to the active ingredient in Metamucil®

fiber Smooth Texture Sugar Free

Bulk-forming laxative and Dietary fiber supplement

100% Natural Psyllium Seed Husk Fiber

Orange Flavor

Naturally and Artificially Flavored

net wt 10 oz (283 g)

48 teaspoon doses

INGREDIENTS AND APPEARANCE

SUNMARK FIBER SMOOTH TEXTURE 
psyllium husk powder, for suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-090
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	3.4 g  in 5.8 g

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-090-92	283 g in 1 CANISTER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	12/27/2006

Labeler - McKesson (177667227)