FDA Label for Onelax Fiber Therapy Original Coarse
View Indications, Usage & Precautions
Onelax Fiber Therapy Original Coarse Product Label
The following document was submitted to the FDA by the labeler of this product Akron Pharma Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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Drug Facts
Active Ingredient: (In Each Teaspoon)
Psyllium husk approximately 3.4 g
Purpose
Bulk-forming Laxative
Uses:
- for relief of occasional constipation (irregularity)
- generally produces bowel movement in 12-72 hours
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.
Otc - Ask Doctor
Ask a doctor before use if you have
- a sudden change in bowel habits persisting for 2 weeks
- abdominal pain, nausea or vomiting
Otc - Stop Use
Stop use and ask a doctor if
- constipation lasts more than 7 days
- rectal bleeding occurs
These may be signs of a serious condition.
Otc - 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 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
- 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, maltodextrin, orange flavor, sodium benzoate, sucralose.
Questions Or Comments ?
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