DR. FIBRA- psyllium husk powder 
Pharmadel LLC

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Dr. Fiber (V)

Drug Facts

Active ingredient and Purpose

Active ingredient (in each packet)Purpose
Psyllium seed husk 3.4 g....................Bulk-forming laxative

Uses

For relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 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.

Allergy Alert: This product may cause allergic reactions in people, sensitive to inhaled or ingested psyllium.

Do not use

  • if allergic to any ingredient in this product

Ask a doctor before use if you have

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

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

  • take this product 2 hours before or after other drugs

Stop use and ask a doctor if

• constipation lasts more than 7 days
• rectal bleeding occurs
• you fail to have a bowel movement after use of a laxative. These may be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

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 of age and older

1 packet up to 3 times a day

children 6 to under 12 years of age

1/2 packet up to 3 times a day

children under 6 years of age

consult a doctor

First time users: Start with the 1 packet per day, gradually increase to 3 times a day, as necessary. As your body adjust to increased fiber intake, you may experience changes in bowel habits and/or minor bloating.

Other information

Inactive ingredients

anhydrous citric acid, FD&C yellow #6, flavors, povidone k-30, sodium bicarbonate, sucralose

Questions?

+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com

Dist. by:

Pharmadel LLC.

New Castle, DE 19720

Principal Display Panel

Dr Fibra PDP BOX

DR. FIBRA 
psyllium husk powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-418
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
POVIDONE K30 (UNII: U725QWY32X)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-418-1010 in 1 BOX06/30/2024
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00706/30/2024
Labeler - Pharmadel LLC (030129680)

Revised: 7/2024
Document Id: 1ddc7cb3-05e6-6453-e063-6294a90a620a
Set id: 1a6151c9-e1c4-f0c1-e063-6394a90aad24
Version: 2
Effective Time: 20240722
 
Pharmadel LLC