CVS NATURAL FIBER EFFERVESCENT- psyllium husk powder

CVS by

Drug Labeling and Warnings

CVS by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each PACKET)

Psyllium husk approximately 3.4 g

Purpose

Fiber therapy for regularity

Uses

• for relief of occasional constipation (irregularity)

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 doctor or a Poison Control Center right away. (1-800-222-1222)

Directions

Put one packet 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 yrs. & older:

  1 packet 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.

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 increase to 3 doses per day as necessary.

Other information

• each packet contains: potassium 30 mg; sodium 194.0 mg
• PHENYLKETONURICS: CONTAINS PHENYLALANINE, 29.0 mg per teaspoon
• store at room temperature tightly closed to protect from humidity
• do not use if printed package is torn or punctured
• contains a 100% natural, therapeutic fiber

Inactive ingredients

anhydrous citric acid, aspartame, flavors, sodium bicarbonate, sucralose, yellow no 6.

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Distributed By: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket RI 02895

CVS.com

1-800-SHOP CVS

PRINCIPAL DISPLAY PANEL

Natural Daily Fiber Effervescent

Smooth Dissolving
100% Natural Psyllium Husk Fiber Supplement

Compare to the active ingredient in Metamucil® MultiHealth Fiber

Sugar Free

Therapy for regularity as part of a healthy lifestyle

Promotes digestive health

Helps lower cholesterol to promote heart health

Orange

Naturally and Artificially Flavored

30 Packets

INGREDIENTS AND APPEARANCE

CVS  NATURAL FIBER EFFERVESCENT
psyllium husk powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-535
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)
citric acid monohydrate (UNII: 2968PHW8QP)
FD&C Yellow No. 6 (UNII: H77VEI93A8)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-535-30	30 in 1 CARTON
1		3.4 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/28/2014

Labeler - CVS Pharmacy (062312574)