DG HEALTH SUGAR FREE- fiber therapy psyllium husk powder

DG health by

Drug Labeling and Warnings

DG health by is a Otc medication manufactured, distributed, or labeled by DOLGENCORP, 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

Fiber therapy for regularity

Uses:

• for relief 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.

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 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. Generally produces effect in 12-72 hours.

• 6-11 yrs :

  ½ adult dose in 8 ounces of liquid, up to 3 times daily

• 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 dose per day; gradually increased to 3doses per day as necessary.

Other information:

• ▪ each teaspoon contains: potassium 30 mg; sodium 5 mg
• ▪ PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon
• ▪ store at room temperature tightly closed to protect from humidity
• ▪ do not use if printed seal is broken or missing
• ▪ contains a 100% natural, therapeutic fiber

Inactive ingredients:

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

PRINCIPAL DISPLAY PANEL

NDC: 55910-551-48

DG™ health

Compare to the active ingredient in Metamucil® MultiHealth Fiber*

Sugar Free

Fiber Therapy

100% Natural Psyllium Husk

Daily Fiber Supplement

Therapy for Regularity

• Orange smooth fiber powder
• Helps lower cholesterol to promotes heart health**
• Promotes digestives health†
• Helps maintain healthy blood sugar levels as part of your diet†
• Gluten Free

Orange Flavor

Naturally and Artificially Flavored

48 TEASPOON DOSES

K PAREVE

NET WT 10 OZ (283 g)

fill controlled by weight, not volume

**See fiber supplement information about soluble fiber and heart disease and maintaining healthy blood sugar levels.

†These statement 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 IS BROKEN OR MISSING

*This product is not manufactured or distributed by Procter & Gamble, the distributor of METAMUCIL®.

DISTRIBUTED BY:

DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

INGREDIENTS AND APPEARANCE

DG HEALTH  SUGAR FREE
fiber therapy psyllium husk powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-551
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	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-551-48	283 g in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/16/2019

Labeler - DOLGENCORP, LLC (068331990)