DR. FIBRA- psyllium husk powder

Dr. Fibra by

Drug Labeling and Warnings

Dr. Fibra by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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.

• 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

• each packet contains: potassium 36 mg; sodium 178 mg
• store below 86°F (30°C)

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

INGREDIENTS AND APPEARANCE

DR. FIBRA 
psyllium husk powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-418
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	3.4 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	brown	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-418-10	10 in 1 BOX	06/30/2024
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	06/30/2024

Labeler - Pharmadel LLC (030129680)