ORIGINAL TEXTURE ORANGE FLAVOR  - psyllium husk powder, for suspension 
Sunmark

Disclaimer: 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.

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Sunmark Fiber Original Texture Orange Flavor

Active ingredient (per each rounded tablespoon=11 g)

Psyllium husk 3.4 g

Purpose

Bulk-forming laxative


Uses

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

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:49348-047
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 3.4 g  in 11 g
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCROSE (UNII: C151H8M554)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
Color brown Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49348-047-65 538 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 - Sunmark (177667227)

Revised: 9/2012
Document Id: 9bde93d4-81fc-4461-b77e-5f75d49dd0b6
Set id: 326294b7-541b-4616-be17-ff4f5af5485f
Version: 1
Effective Time: 20120918
 
Sunmark