FIBER THERAPY ORANGE FLAVOR  - psyllium dietary fiber supplement granule, for solution 
Kinray LLC

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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Drug Facts

Active Ingredients (in each teaspoon = 5.4 g)

Psyllium Powder 3.4 gms (approximately)

Purpose

Fiber Laxative / Fiber Supplement

Uses

Fiber Laxative

Fiber Supplement

Warnings

Choking

Allergy alert

Ask a doctor before use if you have

  • a sudden change in bowel habits that persists over a period of 2 weeks
  • abdominal pain, nausea, or vomiting

Stop use and ask a doctor if

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

Keep out of reach of children

In case of overdose, contact a doctor or a Poison Control Center right away

Directions

Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product with enough liquid may cause choking. Do not take if you have difficulty in swallowing. See choking warnings. Stir briskly and drink promptly. if mixture thickens, add more liquid and stir.

LAXATIVE USEDIETARY SUPPLEMENT FIBER USE
Adults 12 years & older
1 rounded teaspoon (5.4 g) in 8 oz. of liquid at the first sign of irregularity. Can be taken up to 3 times daily
1 rounded teaspoon (5.4 g) in 8 oz. of liquid 3 times daily.
Children 6 years to under 12 years
1/2 the adult dose in 8 oz. of liquid, up to 3 times daily
consult a doctor
Children under 6 years
consult a doctor
consult a doctor
1.
Put one dose into an empty glass
2.
Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid.
3.
Taking this product without enough liquid may cause choking. See choking warining.
4.
Stir briskly and drink immediately. If mixture thickens, add more liquid and stir. An additional glass of liquid is recommended.

Bulk forming fibers like psyllium may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increase fiber intake, you may experience changes in bowel habits or minor bloating.

New Users: Your doctor can recommend the right dosage of this product to best meet your needs. In general, start by taking one dose a day. Gradually increase to three doses per day, if needed or recommeded by your doctor.

Other information

Inactive Ingredients

citric acid, and maltodextrin

Product Label

Outer Label

FIBER THERAPY ORANGE FLAVOR  
psyllium dietary fiber supplement granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-130
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 5.4 g
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorORANGE (ORANGE) Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-130-13283 g in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/28/2014
Labeler - Kinray LLC (012574513)

Revised: 9/2014
Document Id: 90e8a135-fabc-4e02-8857-ff4ad40de1a8
Set id: bb6f5b6a-5111-4e50-8897-74e8ab859cfd
Version: 1
Effective Time: 20140928
 
Kinray LLC