Baby Calm + Comfort

Product Overview

Brand: Culturelle Baby

Barcode: 0 49100 40060 0

Net Contents: 0.29 Fluid Ounce(s); 8.5 mL

Serving Size (Overview): 5 Drop(s)

Product Type: Other Combinations [A1325]

Form: Liquid [E0165]

Date Entered: Apr 23, 2020

Market Status: On Market

Suggested Use (Overview): 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.

Product Self-Roles:

No specific self-roles defined.

Dietary Supplement Facts

Ingredient	Category	Amount Per Serving	Unit	% Daily Value	Target Group	Serving Size (Fact)
Calories	other	N/A	Calorie(s)	N/A	N/A	5 Drop(s)
Total Carbohydrates	sugar	N/A	Gram(s)	N/A	Infants	5 Drop(s)
Total Sugars	sugar	N/A	Gram(s)	N/A	Infants	5 Drop(s)
Added Sugars	sugar	N/A	Gram(s)	N/A	Infants	5 Drop(s)
Lactobacillus rhamnosus GG	bacteria	N/A	N/A	N/A	Infants	5 Drop(s)
German Chamomile flower extract	botanical	1	mg	N/A	Infants	5 Drop(s)

Other Ingredients

Rice Bran Oil; Carnauba Wax; Sucrose; Maltodextrin; Sodium Ascorbate

Label Statements

Precautions

Warning: Keep out of reach of children. Inform a healthcare professional before starting any dietary supplement particularly if there is a known immune-compromised condition. 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. For questions concerns or to report an adverse event please call (800) 722-3476. Tamper Evident: Do not use if bottle or dropper appears to be opened. While there are no dairy-derived ingredients in this product it is produced in a facility that also handles dairy ingredients.

Formulation

Contains none of the following: artificial dyes preservatives dairy sugar lactose milk yeast soy or gluten. Meets the FDA's guidelines for gluten-free. Contains sucrose which adds a dietarily insignificant amount of sugar. Not a reduced calorie food. Helps reduce fussiness & cryingDue to occasional digestive upset. Probiotic + chamomile drops Helps reduce occasional digestive upset 0-12 months With chamomile extract 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.ProbioticThe 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.+ ChamomileWith chamomile extract

Product Specific Information

Storage Instructions: Store Culturelle in a cool dry place away from direct sunlight. Guaranteed potency through date on box when stored as directed.

Other

For children over 1 year: Take Culturelle Baby Grow + Thrive Packets as directed on the package. #1 Pediatrician recommended brandBased on a 2018 survey among pediatricians recommending a probiotic brand.

Statement of Identity

Probiotic Supplement with Chamomile 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 Use

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.

Branding Statement(s)

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