ONELAX FIBER THERAPY ORIGINAL COARSE- psyllium husk powder 
Akron Pharma Inc.

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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OneLAX Fiber Therapy
100% Natural Psyllium Husk
Multihealth Dairy Fiber Supplement

Drug Facts

Active ingredient: (in each teaspoon)

Psyllium husk approximately 3.4 g

Purpose

Bulk-forming Laxative

Uses:

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.

Allergy alert:

This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.

Ask a doctor before use if you have

  • a sudden change in bowel habits persisting for 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, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions:

Put one dose into an empty glass. Mix 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. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.

Adults & children 12 years & older:

1 rounded teaspoon in 8 ounces of liquid at the first sign of irregularity. Can be taken up to 3 times daily.

Children 6 – 11 yrs:

½ adult dose in 8 ounces of liquid, up to 3 times daily

Children under 6 yrs:

Consult a doctor

Bulk forming fibers like psyllium husk 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 increased fiber intake, you may experience changes in bowel habits or minor bloating.

New Users

Start with 1 serving per day; gradually increased to desired daily intake. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.

Other information

Inactive ingredients

citric acid, colloidal silicon dioxide, FD&C Yellow No.6, sucrose, orange flavor, sodium benzoate, sucralose.

Questions or comments ?

Call toll-free 1-877-225-6999.

Supplement Facts

SF

13oz

ONELAX FIBER THERAPY  ORIGINAL COARSE
psyllium husk powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-6585
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 7 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Sucrose (UNII: C151H8M554)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-6585-3368 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/2023
Labeler - Akron Pharma Inc. (067878881)

Revised: 3/2023
Document Id: a32af723-fd8e-45fd-bcef-d582d922896c
Set id: 21b45187-34dc-4eb0-a167-2e843e08c35c
Version: 1
Effective Time: 20230318
 
Akron Pharma Inc.