1936A-Major

Drug Labeling and Warnings

Drug Details [pdf]

NATURAL FIBER THERAPY NATURAL LAXATIVE NATURAL LAXATIVE- psyllium husk powder, for solution 
Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

1936A-Major

BULK FORMING LAXATIVE / DIETARY FIBER SUPLEMENT

SUGAR FREE

SMOOTH TEXTURE

Dosage Adults 12 years & older: 1 rounded TEASPOON 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.

Notice Take this product with at least 8 ounces (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you have difficulty swallowing. See warnings.

Supplement Facts
Serving Size 1 rounded teaspoon (5.8g)
Servings Per Container 48
Amount Per Serving	%DV**
Calories 20
Total Carbohydrates 5 g	2%
Dietary Fiber 3 g	12%
Soluble Fiber 2 g	*
Sugars 0 g	*
Iron 0.8 mg	4%
Sodium 5mg	<1%
Potassium 30mg	<1%
**Percent Daily Values (DV) are based on a 2,000 Calorie diet.
*Daily Value (DV) not established.

Ingredient: psyllium husk, maltodextrin, citric acid, natural orange flavor, aspartame, FD&C Yello # 6 and FD&C yellow No. 6 lake

FIBER LAXATIVE

Drug Facts

Active ingredient

(in each rounded TEASPOON)

Psyllium Husk, approximately 3.4 g

Purpose

Bulk-forming ​laxative

Uses

• effective in treating occasional constipation and restoring 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
• recta bleading occurs

These may be signs of a serious condition.

Keep out of reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

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 & Childrent 12 years & over: 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.
• Children 6 to under 12 yrs.: 1/2 adult dose in 8 oz of liquid, up to 3 times daily.
• Children under 6 yrs.: Consult a doctor.

Laxatives, including bulk fibers, 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 increase to 3 doses per day as necessary.

Other information

• each teaspoon contains: potassium 30 mg; sodium 5 mg
• Phenylketonurics: phenylalanine 25 mg
• store below 30ºC (86ºC) 
• protect contents from humidity
• keep tightly closed

Inactive Ingredient:

aspartame, citric acid, fd&c yellow no. 6, fd&c yellow no. 6 lake, maltodextrin and natural orange flavor

†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Metamucil ®.

Distributed by:
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
LIVONIA, MI 48150 USA

Questions?

 Call toll free: (800) 616-2471

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 0904-5788-77

Natural Fiber Therapy Orange Flavor
(Psyllium Husk)
10 oz (284g)

NATURAL FIBER THERAPY NATURAL LAXATIVE  NATURAL LAXATIVE
psyllium husk powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5788
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 7 g

Inactive Ingredients
Ingredient Name	Strength
ORANGE (UNII: 5EVU04N5QU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ASPARTAME (UNII: Z0H242BBR1)

Product Characteristics
Color	brown (Tanish-yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5788-77	284 g in 1 BOTTLE; Type 0: Not a Combination Product	08/02/2011	05/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/02/2011	05/31/2019

Labeler - Major Pharmaceuticals (191427277)

Registrant - Contract Pharmacal Corp. (057795122)

Revised: 8/2019

Document Id: 9091e0ee-3163-41b4-e053-2a95a90a5dd3

34390-5

Set id: 48be475f-3429-4d8a-a3fd-09b888e79e1e

Version: 2

Effective Time: 20190820