Dr. Fiber (v)

SPL v2

SPL

SPL Set ID 1a6151c9-e1c4-f0c1-e063-6394a90aad24

Route

ORAL

Published

Effective Date 2024-07-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Psyllium Husk (3.4 g)

Inactive Ingredients

Anhydrous Citric Acid Sodium Bicarbonate Fd&c Yellow No. 6 Povidone K30 Sucralose

Identifiers & Packaging

Pill Appearance

Color: brown

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-06-30

Description

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

Medication Information

Description

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.

Section 55105-1

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

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.

Dist. By:

Pharmadel LLC.

New Castle, DE 19720

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.

Do Not Use

if allergic to any ingredient in this product

Questions?

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

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

Principal Display Panel

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.

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.

Structured Label Content

Uses

For relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.

Section 55105-1 (55105-1)

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

Warnings

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

Dist. By: (Dist. by:)

Pharmadel LLC.

New Castle, DE 19720

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

Do Not Use (Do not use)

if allergic to any ingredient in this product

Questions?

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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

When Using This Product (When using this product)

take this product 2 hours before or after other drugs

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you)

are taking any other drug. Laxatives may affect how other drugs work.

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BICARBONATE", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PSYLLIUM HUSK", "unii": "0SHO53407G", "classCode": "ACTIB", "strengthNumerator": "3.4", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.", "55105-1": "Active ingredient (in each packet) Purpose Psyllium seed husk 3.4 g.................... Bulk-forming laxative", "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.", "Dist. by:": "Pharmadel LLC. New Castle, DE 19720", "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.", "Do not use": "if allergic to any ingredient in this product", "Questions?": "+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com", "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", "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.", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:19.623189 · Updated: 2026-03-14T23:03:20.235753