Drugplain

Natural Orange Flavor Organic Natural Fiber 3.4 g/12g

Psyllium husk · POWDER · Raritan Pharmaceuticals Inc

No Recall History
Plain English

Natural Orange Flavor Organic Natural Fiber is a powder containing psyllium husk at 3.4 g/12g, taken oral. Manufactured by Raritan Pharmaceuticals Inc.

Key Facts

Brand Name
Natural Orange Flavor Organic Natural Fiber
Generic Name
Psyllium husk
NDC Code (Product)
68163-571
Manufacturer
Raritan Pharmaceuticals Inc
Strength
3.4 g/12g
Dosage Form
POWDER
Route
ORAL
Marketing Status
Application #
M007
Marketing Start
03/20/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use244 reports
pain228 reports
exposure during pregnancy218 reports
hypertension212 reports
constipation210 reports
headache210 reports
intentional product misuse194 reports
hyperhidrosis177 reports
joint swelling177 reports
food allergy176 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use for relief of occasional constipation (regularity)

Dosage & Administration

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 thickness, add more liquid and stir. Adults 12 years & older: 1 rounded TABLESPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours. Children under 12 yrs: Consult a doctor before use 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 increase fiber intake, you may experience changes in bowel habits or minor bloating. New Users: Start with 1 serving per day, gradually increase to desired daily intake. You may initially experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake. Keep Out of Reach of Children

Warnings

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 reaction in people sensitive to inhaled or ingested psyllium. Ask a doctor before use if you have ▪ a sudden change in bowel habits persisting for 2 weeks. ▪ abdominal pain, nausea or vomiting Stop use and ask a doctor ▪ constipation lasts more than 7 days ▪ rectal bleeding occurs These may be sings of a serious condition 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.

Frequently Asked Questions

What is Natural Orange Flavor Organic Natural Fiber used for?

Natural Orange Flavor Organic Natural Fiber contains Psyllium husk. It is a powder taken oral. Consult your doctor for specific uses.

Is Natural Orange Flavor Organic Natural Fiber a controlled substance?

Natural Orange Flavor Organic Natural Fiber is not classified as a controlled substance by the DEA.

What is the generic name for Natural Orange Flavor Organic Natural Fiber?

The generic name for Natural Orange Flavor Organic Natural Fiber is Psyllium husk. There are 11 other brand versions of Psyllium husk.

What is the NDC code for Natural Orange Flavor Organic Natural Fiber 3.4 g/12g?

The NDC (National Drug Code) for Natural Orange Flavor Organic Natural Fiber 3.4 g/12g is 68163-571, listed by Raritan Pharmaceuticals Inc.