KONSYL Sugar Free Orange Flavor Psyllium Fiber description, usages, side effects, indications, overdosage, supplying and lots more!

KONSYL Sugar Free Orange Flavor Psyllium Fiber

Konsyl Pharmaceuticals, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
KONSYL Sugar Free Orange Flavor Psyllium Fiber

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

KONSYL Sugar Free Orange Flavor Psyllium Fiber

Active Ingredient (in each teaspoon)

                                      
Psyllium Hydrophilic Mucilloid 3.5 g

Purpose

  • Laxative

Uses

For relief of occasional constipation and to induce regularity. This product generally produces bowel movement within  12-72 hours.

Warnings

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.

Do not use

  • when abdominal pain, nausea or vomiting are present unless directed by a doctor
  • If constipation lasts more than seven days
  • if you have difficulty swallowing

Ask a doctor before use if you have

  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

  • you experience rectal bleeding or fail to have a bowel movement, as these may 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

Mix this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough fluid may cause choking. See choking warning.

adults and children 12 years and older
one teaspoon 1 to 3 times daily
children 6 to under 12 years of age
1/2 teaspoon 1 to 3 times daily
children under 6 years of age
consult a doctor.

Other information

  • each 5.8g dose contains Potassium 25mg
  • Phenylketonurics: Contains phenylalanine, 21 mg per teaspoon
  • laxatives, including bulk fibers, may affect how other medicines work, wait 1-2 hours before or after taking other medicines
  • tamper-evident bottle mouth sealed for your protection
  • do not use if imprinted inner seal is broken or missing
  • do not discard Konsyl into any plumbing system
  • store below 86  degrees F (30 degrees C)
  • keep container tightly closed-protect from excessive moisture
  • can be taken before or after meals, mornings or evenings

Inactive Ingredients

Aspartame, Citric Acid, FD and C Yellow No. 6, Maltodextrin, Natural and Artificial Orange Flavor, Silicon dioxide.

Questions or Comments?

1-800-356-6795 8:30 a.m. to 5 p.m. ET.

Representative Labeling

Representative Labeling

KONSYL Sugar Free Orange Flavor Psyllium Fiber

PSYLLIUM HUSK GRANULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0224-1855
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Psyllium Husk PSYLLIUM HUSK 3.5 g

Inactive Ingredients

Ingredient Name Strength
ASPARTAME
CITRIC ACID MONOHYDRATE
FD&C YELLOW NO. 6
maltodextrin
SILICON DIOXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5.8 in 1 PACKET
2 5.8 in 1 PACKET
3 NDC:0224-1855-06 300 in 1 CANISTER
4 NDC:0224-1855-07 450 in 1 CANISTER
5 NDC:0224-1855-81 450 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2011-03-31


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Be sure to consult your doctor before taking any medication!
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