Label: CVS NATURAL FIBER EFFERVESCENT- psyllium husk powder
- NDC Code(s): 59779-535-30
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated February 28, 2013
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each PACKET)
Psyllium husk approximately 3.4 gClose
Fiber therapy for regularityClose
- for relief of occasional constipation (irregularity)
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.
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)
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.Close
- 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.Close
- SPL UNCLASSIFIED SECTION
Distributed By: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket RI 02895
- PRINCIPAL DISPLAY PANEL
Natural Daily Fiber Effervescent
100% Natural Psyllium Husk Fiber Supplement
Compare to the active ingredient in Metamucil® MultiHealth Fiber
Therapy for regularity as part of a healthy lifestyle
Promotes digestive health
Helps lower cholesterol to promote heart health
Naturally and Artificially Flavored
- 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)