Baby Calm + Comfort

Basic Information

Product Label

Product label for Baby Calm + Comfort
Full Name: Baby Calm + Comfort
Brand: Culturelle Baby ®
Product Type: Other Combinations
Physical State: Liquid
UPC/SKU: 0 49100 40052 5
Status: Off Market
Product Version Code: CBBM4537

Contact Information

Distributed by

Name: i-Health, Inc.
Address:55 Sebethe Drive, Cromwell, CT, 06416
Phone: (800) 722-3476
Website: www.culturelle.com
Types: Distributor

Product Details

Net Contents

0.29 Fluid Ounce(s)(0.29 Fluid Ounce(s))
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

Amount: 0 Calorie(s)
Serving Size: 5 Drop(s)

Group: Calories

UNII Code: 1

Amount: 1 mg
Serving Size: 5 Drop(s)
Infants: % (Daily Value not established)

Group: Chamomile

Notes: Lactobacillus rhamnosus GG (Alt. Name: LGG) Genus: Lactobacillus Species: rhamnosus Note: 1.5 billion CFUs

Amount: 0 NP
Serving Size: 5 Drop(s)
Infants: % (Daily Value not established)

Group: Lactobacillus rhamnosus

Also known as: LGG

UNII Code: 4VNZ1M3QXY

Amount: 0 Gram(s)
Serving Size: 5 Drop(s)
Infants: 0%

Group: Carbohydrate

UNII Code: 0

Carnauba Wax

non-nutrient/non-botanical

Group: Carnauba wax

Group: Digestion resistant Maltodextrin

Also known as: maltodextrin

Maltodextrin

complex carbohydrate

Group: Maltodextrin

Also known as: Fibersol-2, DuraCarb

UNII Code: 7CVR7L4A2D

Group: Rice Oil

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: 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: Children

If your infant develops an allergic reaction such as a rash, itching, wheezing or hives, discontinue use and call your doctor. When first taking a probiotic, your baby's gut microbiom adjusts. Your baby may experience minor bloating, gas or intestinal gurgling which should subside with continued use. Consult your healthcare professional if symptoms continue after two weeks.

Precautions re: All Other

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

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. Guaranteed potency through date on box when stored as directed.

Precautions re: All Other

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

Suggested/Recommended/Usage/Directions

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

Precautions re: All Other

While there are no dairy-derived ingredients in this 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.

Formulation re: Other

Helps reduce fussiness & crying Due to occasional digestive upset.

General Statements: All Other Content

#1 Pediatrician recommended brand Based on a 2018 survey among pediatricians recommending a probiotic brand.

Formula re: Contains

Probiotics Probiotic + chamomile drops

Formulation re: Other

Helps reduce occasional digestive upset

General Statements: All Other Content

0-12 months

Formula re: Contains

Calm + Comfort With chamomile extract

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 well 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.

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

Culturelle Baby Calm + Comfort helps you soothe your baby.

Formula re: Contains

Contains the most clinically studied probiotic in infants, lacobacillus rhamnosus GG, to help support a healthy digestive and immune system.

Formula re: Contains

Culturelle Baby Calm + Comfort contains safe and gentle ingredients that work naturally with your baby's body to help reduce fussiness and crying. The most clinically studied probiotic in infants, lacobacillus rhamnosus GG, restores the natural balance of good bacteria in their digestive tract to help reduce occasional digestive upset. Based on the number of lactobacillus rhamnosus GG studies, as of January 2018. With chamomile extract

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