Your browser does not support JavaScript! ORIGINAL TEXTURE ORANGE FLAVOR (PSYLLIUM HUSK) POWDER, FOR SUSPENSION [SUNMARK]
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ORIGINAL TEXTURE ORANGE FLAVOR (psyllium husk) powder, for suspension
[Sunmark]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient (per each rounded tablespoon=11 g)

Psyllium husk 3.4 g

Purpose

Bulk-forming laxative


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 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 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 havbe difficulty swallowing.  See choking warning.

PDP

Sunmark

compare to the active ingredient in Metamucil®

fiber Original Texture

Bulk-forming laxative

Dietary fiber supplement

100% Natural Psyllium Seed Husk Fiber

Orange Flavor

Naturally and Artificially Flavored

48 Tablespoon doses

Net wt 19 oz  (1.1 LBS 3 OZ) (538 g)

Fill controlled by weight, not volumeoriginal texture orange flavor

ORIGINAL TEXTURE ORANGE FLAVOR  
psyllium husk powder, for suspension
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49348-047
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK3.4 g  in 11 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
SUCROSE 
ANHYDROUS CITRIC ACID 
FD&C YELLOW NO. 6 
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-047-65538 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/27/2006
Labeler - Sunmark (177667227)

Revised: 9/2012
 
Sunmark

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