FDA Label for Cvs Natural Fiber Effervescent

View Indications, Usage & Precautions

Cvs Natural Fiber Effervescent Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts

Distributed By: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket RI 02895

CVS.com

1-800-SHOP CVS


Active Ingredient (In Each Packet)



Psyllium husk approximately 3.4 g


Purpose



Fiber therapy for regularity


Uses



  • •for relief of occasional constipation (irregularity)

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.


Otc - Ask Doctor



Ask a doctor before use if you have

  • •a sudden change in bowel habits persisting for 2 weeks
  • •abdominal pain, nausea or vomiting

Otc - Stop Use



Stop use and ask a doctor if

  • •constipation lasts more than 7 days
  • •rectal bleeding occurs
  • These may be signs of a serious condition.


Otc - Keep Out Of Reach Of Children



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.


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


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