LIDL ORANGE SMOOTH FIBER POWDER SUGAR FREE NATURALLY AND ARTIFICIALLY FLAVORED- natural psyllium husk powder

LIDL Orange Smooth Fiber Powder Sugar Free by

Drug Labeling and Warnings

LIDL Orange Smooth Fiber Powder Sugar Free by is a Otc medication manufactured, distributed, or labeled by LIDL US, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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 if

• ▪ constipation lasts more than 7 days
• ▪ rectal bleeding occurs

These may be signs 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 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 oz 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 oz 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.

New Users:

Start with 1 serving per day; gradually increased to 3 doses per day as necessary. 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
• ▪ PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon
• ▪ contains a 100% natural, therapeutic fiber
• ▪ store at room temperature tightly closed to protect from humidity

Inactive ingredients:

aspartame, citric acid, FD&C yellow 6, maltodextrin, natural and artificial orange flavor, silica.

Questions or comments?

1-844-656-5151

PRINCIPAL DISPLAY PANEL

SUGAR FREE

NDC: 71141-146-32

ORANGE SMOOTH

FIBER POWDER NATURALLY & ARTIFICIALLY FLAVORED

Compare to Psyllium in Metamucil® 4 in 1 Multihealth Fiber*

Fiber POWDER

100% NATURAL PSYLLIUM HUSK

Bulk forming laxative/fiber supplement

THERAPY FOR REGULARITY

• ▪ Helps you feel less hungry between meals**
• ▪ Helps maintain healthy blood sugar levels as part of your diet**
• ▪ Helps lower cholesterol to promote heart health†
• ▪ Promotes digestive health**
• ▪ Gluten free

NET WT 23 OZ (660g)

fill controlled by weight, not volume

†See back for information about soluble fiber and heart disease.

**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.

DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil® 4 in 1 MultiHealth Fiber*.

GLUTEN FREE if you have specific dietary needs, you should consult your doctor before consuming this product.

This product has a low glycemic index, a measure of the effect of dietary carbohydrates on blood sugar levels.

DISTRIBUTED BY:

Lidl US, LLC

3500 S. Clark Street

Arlington, VA 22202

QUESTIONS?

1-844-656-5151

www.lidl.com

INGREDIENTS AND APPEARANCE

LIDL ORANGE SMOOTH FIBER POWDER SUGAR FREE  NATURALLY AND ARTIFICIALLY FLAVORED
natural psyllium husk powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71141-146
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 5.8 g

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C Yellow No. 6 (UNII: H77VEI93A8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	BROWN (Light Yellowish)	Score
Shape		Size
Flavor	ORANGE (natural and artifcial)	Imprint Code	RP146
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71141-146-32	660 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	11/15/2018

Labeler - LIDL US, LLC (079389709)