NATURAL ORANGE FLAVOR ORGANIC NATURAL FIBER- psyllium husk powder

Natural Orange Flavor by

Drug Labeling and Warnings

Natural Orange Flavor by is a Otc medication manufactured, distributed, or labeled by Raritan Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each TABLESPOON)

Psyllium Hydrophilic Mucilloid 3.4g

Purpose

Fiber therapy for regularity

Use

for relief of occasional constipation (regularity)

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.

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.

Directions:

Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 oz (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

Other information

• ▪ each tablespoon contains: potassium 35 mg; sodium 5 mg
• ▪ Store at room temperature tightly closed to protect from humidity
• ▪ Do not use if printed seal under cap is torn or missing
• ▪ Contains a 100% natural, therapeutic fiber

‡Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from fiber such as NuSyllium may reduce the risk of heart disease by lowering cholesterol.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Questions or comments?

1-866-467-2748

Inactive ingredients

Natural citric acid, natural flavors, Organic Brown Cane Sugar, Organic Vegetable Glycerin.

Principal Display Panel

NDC 68163-571-72

NuSyllium

Natural Orange Flavor

Organic Natural Fiber

100% Organic Certified Psyllium

Perfect Grind For Easy Mixing™

USDA ORGANIC

NO ARTIFICIAL INGREDIENTS

100% Natural Fiber Supplement

Fiber Laxative for Regularity

Made with 100% Organic Brown Cane Sugar

Folks are taking about the Benefits of NuSyllium Organic Natural Fiber!

• You can use NuSyllium to feel less hungry between meals.
• Maintain healthy blood sugar levels by using NuSyllium Ultra as part of your sugar free diet*. Talk to your doctor before use if you are taking medication to control your blood sugar levels.
• Organic NuSyllium is a great choice for promoting and maintain digestive health. You can use NuSyllium Ultra for occasional constipation and to help promote and maintain regularity.
• Did you know that one dose of NuSyllium Ultra contains 2 gm. of soluble fiber? You can use it for lowering cholesterol and promoting heart health*.

No Artificial Flavors, Peanut-free

No Artificial Colors, Tree Nut-free

GMO-free, Preservative-free

Gluten-free, Zero Trans Fat

Diary-free

NET WT 30.5 OZ (864 g) 72 DOSES

Fill controlled by weight, not volume

Made in the U.S.A. with domestic and foreign components.

Distributed by: Lifelab Health LLC

6574 N.State Road #7 361

Coconut Creek, FL 33073

INGREDIENTS AND APPEARANCE

NATURAL ORANGE FLAVOR  ORGANIC NATURAL FIBER
psyllium husk powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68163-571
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  in 12 g

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
RAW SUGAR (UNII: 8M707QY5GH)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor	ORANGE (Natural)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68163-571-72	864 g in 1 CANISTER; Type 0: Not a Combination Product	03/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/20/2019

Labeler - Raritan Pharmaceuticals Inc (127602287)