EQUATE SUGAR FREE FIBER THERAPY SMOOTH TEXTURE ORANGE FLAVOR- psyllium husk granule, for solution

equate Sugar Free Fiber Therapy Smooth Texture Orange Flavor by

Drug Labeling and Warnings

equate Sugar Free Fiber Therapy Smooth Texture Orange Flavor by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc, Konsyl Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

equate Sugar Free Fiber Therapy Smooth Texture Orange Flavor

Active Ingredient

• Psyllium husk 3.5g

Purpose

Bulk-forming laxative

Uses

•  for relief of occasional constipation and restoring regularity
• generally produces bowel movement in 12-72 hours
  

Warnings

Allergy alert: may cause allergic reaction in people sensitive to inhaled or ingested psyllium
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

•  abdominal pain, nausea, vomiting or rectal bleeding
  
• a sudden change in bowel habits that persist over a period of 2 weeks
• constipation associated with gastrointestinal disorders
  

Ask a pharmacist before use

if you are taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may effect how other drugs work.

Stop use and ask a doctor if

• you experience rectal bleeding
• you fail to have a bowel movement after use of a laxative These could 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. (1-800-222-1222)

Directions

This product generally produces effect in 12-72 hours. Put one dose into an empty glass. Fill glass with at least 8 oz of water or your favorite beverage. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.

• mix this product (child or adult) dose with at least 8 ounces (a full glass) of water or other liquid
• taking this product without enough liquid may cause choking, see choking warning
• can be taken before or after meals

• Age: Dose
• adults and children 12 years and older: 1 level teaspoonful (5.8g) sprinkled in 8 oz of liquid, up to 3 times daily
• children 6 to under 12 years: 1/2 adult dose in 8 oz. of liquid, up to 3 times daily
• children under 6 years: consult a doctor

Other information

• each dose contains: calcium 6 mg; potassium 30 mg; sodium 5 mg
• PHENYLKETONURICS:Contains phenylantanine, 21mg per teaspoonful
  
• store below 30 oC (86 oF), tightly closed to protect from humidity
  

Inactive Ingredients

apsartame, citric acid, FD and C Yellow #6, (Sunset Yelow), flavoring, maltodextrin, silicon dioxide

Distributed by:

• Wal-Mark Stores, Inc, Bentonville, AR 72716 Wal-Mart Stores, Inc, This product is not manufactured or distributed by Procter and Gamble, owner of the registered trademark Metamucil MultiHealth 34729 0312

Package Labeling

Package Labeling

INGREDIENTS AND APPEARANCE

EQUATE SUGAR FREE FIBER THERAPY SMOOTH TEXTURE ORANGE FLAVOR 
psyllium husk granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-066
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	3.5 g  in 5.8 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)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-066-23	661 g in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2012	05/01/2020
2	NDC: 49035-066-48	1043 g in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2012	05/01/2020
3	NDC: 49035-066-39	283 g in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2012	05/01/2020
4	NDC: 49035-066-81	661 g in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2012	05/01/2020
5	NDC: 49035-066-83	1043 g in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2012	05/01/2020
6	NDC: 49035-066-82	283 g in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2012	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/05/2012	05/01/2020

Labeler - Wal-Mart Stores Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
Konsyl Pharmaceuticals, Inc		102463866	manufacture(49035-066)