CAREONE- psyllium husk capsule

CAREONE by

Drug Labeling and Warnings

CAREONE by is a Otc medication manufactured, distributed, or labeled by FOODHOLD USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

Psyllium husk approximately 0.52 g

Purpose

Fiber 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
• ▪ 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 Poison Control Center right away at 1-800-222-1222.

Directions

• ▪ Take this product 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.
• ▪ Adults 12 years and older: 5 capsules with at least 8 oz. of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.
• ▪ children 12 years and under: Ask a doctor
• ▪ Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a prescription medication 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.

Other information

• ▪ each capsule contains: potassium 5 mg
• ▪ capsules are sealed using a band around the middle
• ▪ store at room temperature. Keep the container tightly closed to protect from humidity
• ▪ contains a 100% natural, therapeutic fiber
• ▪ tamper evident: do not use if printed inner seal under cap is broken or missing

Inactive ingredients

caramel color, edible ink, gelatin, polysorbate 80

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 160 Capsules Label

NDC 41520-907-60

Compare to Metamucil® Capsules‡

FIBER CAPSULES

Psyllium Husk Fiber Supplement

100% natural Psyllium Husk

BULK FORMING LAXATIVE
DIETARY FIBER SUPPLEMENT

160 CAPSULES

OUR PHARMACISTS RECOMMEND

**THESE STAEMENTS HAVE NOT BEEN EVALUATED BY FOOD AND DRUG ADMINSTRATION, THIS PRODUCT IS NOT INTEDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE

GLUTEN FREE (may contain trace amount less than 20 ppm). If you have specific dietary needs, you should dietary needs; you should consult your doctor before consuming this product)

DISTRIBUTED BY FOODHOLD U.S.A. LLC

LANDOVER, MD 20785

1-877-846-9949

2018 S&S Brands, LLC

Quality guaranteed or your money back.

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil® 3 in1 MultiHealth Fiber!™.

INGREDIENTS AND APPEARANCE

CAREONE 
psyllium husk capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-907
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Psyllium Husk (UNII: 0SHO53407G) (Psyllium Husk - UNII:0SHO53407G)	Psyllium Husk	0.52 g

Inactive Ingredients
Ingredient Name	Strength
CARAMEL (UNII: T9D99G2B1R)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	BROWN	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	RP119
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-907-60	160 in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/16/2019

Labeler - FOODHOLD USA (809183973)