Onelax Fiber Therapy

Onelax Fiber Therapy
SPL v1
SPL
SPL Set ID 21b45187-34dc-4eb0-a167-2e843e08c35c
Route
ORAL
Published
Effective Date 2023-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Psyllium Husk (3.4 g)
Inactive Ingredients
Citric Acid Monohydrate Silicon Dioxide Fd&c Yellow No. 6 Sucrose Sodium Benzoate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-01-01

Description

Drug Facts

Purpose

Bulk-forming Laxative


Medication Information

Purpose

Bulk-forming Laxative

Description

Drug Facts

Uses:
  • for relief of occasional constipation (irregularity)
  • generally produces bowel movement in 12-72 hours
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs

These may be signs of a serious condition.

Section 50569-3

Ask a doctor before use if you have

  • a sudden change in bowel habits persisting for 2 weeks
  • abdominal pain, nausea or vomiting
Section 51945-4

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.

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.

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.

Allergy Alert:

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

Supplement Facts

Other Information
  • each teaspoon contains: potassium 35 mg; sodium 5 mg
  • store at room temperature. Keep the container tightly closed to protect from humidity
  • contains a 100% natural, therapeutic fiber
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.

Active Ingredient: (in Each Teaspoon)

Psyllium husk approximately 3.4 g


Structured Label Content

Uses:
  • for relief of occasional constipation (irregularity)
  • generally produces bowel movement in 12-72 hours
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs

These may be signs of a serious condition.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • a sudden change in bowel habits persisting for 2 weeks
  • abdominal pain, nausea or vomiting
Section 51945-4 (51945-4)

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.

Purpose

Bulk-forming Laxative

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.

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.

Allergy Alert: (Allergy alert:)

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

Supplement Facts

Other Information (Other information)
  • each teaspoon contains: potassium 35 mg; sodium 5 mg
  • store at room temperature. Keep the container tightly closed to protect from humidity
  • contains a 100% natural, therapeutic fiber
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments ? (Questions or comments ?)

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

Active Ingredient: (in Each Teaspoon) (Active ingredient: (in each teaspoon))

Psyllium husk approximately 3.4 g


Advanced Ingredient Data


Raw Label Data

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