SMOOTH TEXTURE ORANGE FLAVOR - psyllium husk powder, for suspension 
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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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Select Brand Smooth texture Orange Flavor Natural Fiber Laxative

Active ingredient (per each rounded tablespoon=12 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

adults and children 12 years and over1 rounded tablespoon                         
6 to under 12 years1/2 tablespoon
under 6 yearsask a doctor

Other information

Inactive ingredients

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

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

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Compare to the active ingredient in Metamucil®

Natural Fiber Laxative

Natural Psyllium Fiber

orange flavor smooth texture

net wt 30.4 OZ. (862 g) 72 tablespoon doses

Fill controlled by weight, not volume

Label

SMOOTH TEXTURE ORANGE FLAVOR  
psyllium husk powder, for suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-872
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-872-30862 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/04/2010
Labeler - Select Brand (043562370)

Revised: 9/2014
Document Id: 6f4739fd-b57b-4279-8406-363b44eaad9f
Set id: da54caed-98dd-45d8-89a3-cf0d622368dc
Version: 1
Effective Time: 20140903
 
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