Calm + Comfort

Basic Information

Product Label

Product label for Calm + Comfort
Full Name: Calm + Comfort
Brand: Culturelle Baby ®
Product Type: Other Combinations
Physical State: Liquid
UPC/SKU: 0 49100 40052 5
Status: Off Market
Product Version Code: CBBM3679

Contact Information

Distributed by

Name: i-Health, Inc.
Address:55 Sebethe Dr., Cromwell, CT, 06416
Phone: 800-722-3476
Website: www.Culturelle.com
Types: Distributor

Product Details

Net Contents

0.29 fl. Oz.(0.29 fl. Oz.)
8.5 mL(8.5 mL)

Serving Sizes

Unit:Drop(s)
Quantity:5 - 5
Daily Servings:1 - 1

Target Groups

Infants/Baby (0 - 1 Year)Gluten FreeDairy FreeSugar Free

Servings Per Container

30

Ingredients & Nutrition

Group: Calories

UNII Code: 1

Carnauba wax

non-nutrient/non-botanical

Group: Carnauba wax

Group: Digestion Resistant Maltodextrin

Fibersol®2 is a soluble fiber derived from maltodextrin that is designed to resist digestion in the small intestine, allowing it to reach the large intestine where it can provide various health benefits. It is often used as a dietary fiber supplement to support digestive health and improve bowel regularity.

Also known as: Digestion Resistant Maltodextrin

Group: German Chamomile

Group: Lactobacillus rhamnosus

Also known as: LGG

UNII Code: 4VNZ1M3QXY

Maltodextrin

Complex Carbohydrate

Group: Maltodextrin

Maltodextrin is a polysaccharide that is commonly used as a food additive. It is produced from starch through partial hydrolysis and is often used as a thickener or filler in processed foods. Maltodextrin is easily digestible and can provide a quick source of energy, making it popular in sports drinks and supplements.

Also known as: Maltodextrin, Dextrin, Maltodextrin Powder

UNII Code: null

Group: Rice Oil

UNII Code: LZO6K1506A

Sodium Ascorbate

non-nutrient/non-botanical

Group: Sodium Ascorbate

Also known as: Na Ascorbate

UNII Code: S033EH8359

Sucrose

sugar

Group: Sucrose

UNII Code: C151H8M554

Group: Carbohydrate

UNII Code: 0

Group: Sugar

UNII Code: 1

Product Statements

Precautions re: Children

Warning: Keep out of reach of children.

Precautions re: All Other

Inform a healthcare professional before starting any dietary supplement, particularly if there is a known immune-compromised condition.

Precautions re: Allergies

If your infant develops an allergic reaction, such as a rash, itching, wheezing or hives, discontinue use and call your doctor.

Precautions re: Children

If your infant develops an allergic reaction, such as a rash, itching, wheezing or hives, discontinue use and call your doctor.

General Statements: All Other Content

For questions, concerns or to report an adverse event, please call (800) 722-3476. www.Culturelle.com

Formulation re: Does NOT Contain

Contains none of the following: artificial dyes, preservatives, dairy, sugar, lactose, milk, yeast, soy or gluten.

Storage

Storage instructions: Store Culturelle in a cool, dry place away from direct sunlight.

Precautions re: All Other

Tamper evident: Do not use if bottle or dropper appears to be opened.

Brand IP Statement(s) re: (c), (TM), (SM)

For children over 1 year: Take Culturelle Baby Grow + Thrive Packets as directed on the package.

General Statements: All Other Content

Due to occasional digestive upset Based on the number of Lactobacillus GG studies, as of May 2017. Based on a 2016 survey among pediatricians recommending a probiotic brand

Precautions re: Allergies

While there are no dairy-derived ingredients in the product, it is produced in a facility that also handles dairy ingredients.

Formulation re: Does NOT Contain

Meets the FDA’s guidelines for gluten-free.

Formula re: Contains

Contains sucrose which adds a dietarily insignificant amount of sugar. Not a reduced calorie food.

Storage

Guaranteed potency through date on box when stored as directed.

Brand IP Statement(s) re: (c), (TM), (SM)

Patent pending. Culturelle is a trademark of DSM. LGG is a trademark of Chr. Hansen A/S.

General Statements: All Other Content

New Helps reduce fussiness & crying #1 pediatrician recommended brand

General Statements: All Other Content

Probiotics

Formula re: Contains

Probiotic + chamomile drops

General Statements: All Other Content

Helps reduce occasional digestive upset

Formula re: Contains

With chamomile extract

Formula re: Type

0-12 months

FDA Statement of Identity

Probiotic Supplement with chamomile

FDA Disclaimer Statement

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Suggested/Recommended/Usage/Directions

Directions for 0-12 months: Use 5 drops once a day. Dispense directly into baby's mouth, bottle or while breastfeeding. Shake before use. Before first use, replace cap with dropper and discard original cap. Washing of dropper in between use is not recommended. Once opened, use within 60 days.

General Statements: All Other Content

Made in Italy.

General: Product/Version Code

CBBM3679

Brand IP Statement(s) re: (c), (TM), (SM)

Culturelle Baby Calm + Comfort helps you soothe your baby. Culturelle Baby Calm + Comfort contains safe and gentle ingredients that work naturally with your baby’s body to help reduce fussiness and crying.

Formula re: Contains

Probiotic The most clinically studied probiotic in infants, Lactobacillus GG, restores the natural balance of good bacteria in their digestive tract to help reduce occasional digestive upset. + Chamomile With chamomile extract.

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