SHOPRITE SUGAR FREE FIBER, ORANGE FLAVOR- psyllium husk powder, for solution

ShopRite Sugar Free Fiber, Orange Flavor by

Drug Labeling and Warnings

ShopRite Sugar Free Fiber, Orange Flavor by is a Otc medication manufactured, distributed, or labeled by WakeFern Food Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each teaspoon)

Psyllium Hydrophilic Mucilloid 3.5 g

Purpose

Bulk-Forming Laxative

Uses

For relief of occasioinal constipation and to induce regularity.  This product generally produces bowel movements within 12-72 hours.

Warnings

​Choking​ Takng this product without adequate fluid may cause ti 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.

Do not use

• when abdominal pain, nausea or vomiting are present unless directed by a doctor
• for more than 1 week unless directed by a doctor
• if you have difficulty swallowing

Ask a doctor before use if you have

• noticed sudden change in bowel habits that persist over a period of 2 weeks.

Stop use and ask a doctor if

• you experience rectal bleeding or fail to have a bowel movement, as 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.

Directions

Mix this product with at least 8 ounces (a full glass) of water or other fluid.  Taking this product without enough fluid may cause choking.  See choking warning.

• adults and children 12 years and older: one teaspoon 1 to 3 times daily
• children 6 to under 12 years of age: 1/2 teaspoon 1 to 3 times daily
• children under 6 years of age: consult a doctor.

Other Information

• each 5.8g dose contains: Potassium 30mg; Sodium 5 mg; Calcium 6 mg.
• Laxatives, including bulk fibers, may affect how other medicines work, wait 1-2 hours before taking other medicines
• tamper-evident bottle mouth sealed for your protection
• do not use if imprinted inner seal is broken or missing
• do not discard into any plumbing system
• store below 86 ​0​ F (30 ​0​C)
• keep container tightly closed-protect from excessive moisture
• can be taken before or after meals, mornings or evenings

Inactive Ingredients

Aspartame, Citric Acid, FD&C Yellow No. 6, Flavoring, Maltodextrin, Silicon Dioxide

Product Label

INGREDIENTS AND APPEARANCE

SHOPRITE SUGAR FREE FIBER, ORANGE FLAVOR 
psyllium husk powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41190-201
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	0.604 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41190-201-00	1 in 1 CARTON	06/04/2015	05/01/2020
1		661 g in 1 CANISTER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/04/2015	05/01/2020

Labeler - WakeFern Food Corp. (069722418)