{"src":"01-raw/2024-12-21/data/label_52.json","id":218190,"nhanesId":"","bundleName":"","fullName":"Baby Calm + Comfort","brandName":"Culturelle Baby","brandIpSymbol":"®","upcSku":"0 49100 40060 0","productVersionCode":"CBBM4537","pdf":"","thumbnail":"","servingsPerContainer":"30","hasOuterCarton":false,"percentDvFootnote":"Not Present","labelRelationships":[{"type":"Image difference, same product","labelId":218179},{"type":"Image difference, same product","labelId":246009},{"type":"Image difference, same product","labelId":177097},{"type":"Image difference, same product","labelId":218199}],"contacts":[{"contactId":19009,"text":"Distributed by","types":["Distributor"],"contactDetails":{"src":"01-raw/2025-09-25/data/contact_4.json","id":19009,"name":"i-Health, Inc.","streetAddress":"55 Sebethe Drive","city":"Cromwell","state":"CT","country":"","zipCode":"06416","phoneNumber":"(800) 722-3476","email":"","webAddress":"www.culturelle.com"}}],"netContents":[{"order":1,"quantity":0.29,"unit":"Fluid Ounce(s)","display":"0.29 Fluid Ounce(s)"},{"order":2,"quantity":8.5,"unit":"mL","display":"8.5 mL"}],"physicalState":{"langualCode":"E0165","langualCodeDescription":"Liquid"},"servingSizes":[{"order":1,"minQuantity":5,"maxQuantity":5,"minDailyServings":1,"maxDailyServings":1,"unit":"Drop(s)","inSFB":true}],"targetGroups":["Infants/Baby (0 - 1 Year)","Gluten Free","Dairy Free","Sugar Free"],"productType":{"langualCode":"A1325","langualCodeDescription":"Other Combinations"},"statements":[{"type":"Precautions re: Children","notes":"Warning: Keep out of reach of children."},{"type":"Precautions re: All Other","notes":"Inform a healthcare professional before starting any dietary supplement, particularly if there is a known immune-compromised condition."},{"type":"Precautions re: Children","notes":"If your infant develops an allergic reaction such as a rash, itching, wheezing or hives, discontinue use and call your doctor. \nWhen 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."},{"type":"Precautions re: All Other","notes":"For questions, concerns or to report an adverse event, please call (800) 722-3476."},{"type":"Formulation re: Does NOT Contain","notes":"Contains none of the following: artificial dyes, preservatives, dairy, sugar, lactose, milk, yeast, soy or gluten."},{"type":"Storage","notes":"Storage Instructions: Store Culturelle in a cool, dry place away from direct sunlight. Guaranteed potency through date on box when stored as directed."},{"type":"Precautions re: All Other","notes":"Tamper Evident: Do not use if bottle or dropper appears to be opened."},{"type":"General Statements: All Other Content","notes":"For children over 1 year: Take Culturelle Baby Grow + Thrive Packets as directed on the package."},{"type":"Precautions re: Allergies","notes":"While there are no dairy-derived ingredients in this product, it is produced in a facility that also handles dairy ingredients."},{"type":"Formulation re: Does NOT Contain","notes":"Meets the FDA's guidelines for gluten-free."},{"type":"Formula re: Contains","notes":"Contains sucrose which adds a dietarily insignificant amount of sugar. \nNot a reduced calorie food."},{"type":"Formulation re: Other","notes":"Helps reduce fussiness & crying\nDue to occasional digestive upset.\n"},{"type":"General Statements: All Other Content","notes":"#1 Pediatrician recommended brand\nBased on a 2018 survey among pediatricians recommending a probiotic brand."},{"type":"Formula re: Contains","notes":"Probiotic + chamomile drops"},{"type":"Formulation re: Other","notes":"Helps reduce occasional digestive upset"},{"type":"Formula re: Type","notes":"0-12 months"},{"type":"Formula re: Contains","notes":"With chamomile extract"},{"type":"FDA Statement of Identity","notes":"Probiotic Supplement with Chamomile"},{"type":"FDA Disclaimer Statement","notes":"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."},{"type":"Suggested/Recommended/Usage/Directions","notes":"Directions for 0-12 Months: \nUse 5 drops once a day. Dispense directly into baby's mouth, bottle or while breastfeeding.\nShake well before use.\nBefore first use, replace cap with dropper and discard original cap.\nWashing of dropper in between use is not recommended.\nOnce opened, use within 60 days."},{"type":"Brand IP Statement(s) re: (c), (TM), (SM)","notes":"Patent pending.\nCulturelle is a trademark of DSM.\nLGG is a trademark of Chr, Hansen A/S."},{"type":"Formula re: Type","notes":"Culturelle Baby Calm + Comfort helps you soothe your baby."},{"type":"Formula re: Contains","notes":"Culturelle Baby Calm + Comfort contains safe and gentle ingredients that work naturally with your baby's body to help reduce fussiness and crying.\nProbiotic\nThe 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.\nBased on the number of lactobacillus rhamnosus GG studies, as of January 2018.\n+ Chamomile\nWith chamomile extract"}],"claims":[{"langualCode":"P0115","langualCodeDescription":"All Other"},{"langualCode":"P0265","langualCodeDescription":"Structure/Function"}],"events":[{"date":"2020-04-23","type":"Date entered into DSLD"}],"userGroups":[{"dailyValueTargetGroupName":"Infants","langualCode":"P0266","langualCodeDescription":"Infants/Children less than 12 months"}],"ingredientRows":[{"order":1,"ingredientId":284519,"description":"","notes":"","quantity":[{"servingSizeOrder":1,"servingSizeQuantity":5,"operator":"=","quantity":0,"unit":"Calorie(s)","dailyValueTargetGroup":[],"servingSizeUnit":"Drop(s)"}],"nestedRows":[],"name":"Calories","category":"other","ingredientGroup":"Calories","uniiCode":"1","alternateNames":[],"forms":[]},{"order":2,"ingredientId":283702,"description":"","notes":"","quantity":[{"servingSizeOrder":1,"servingSizeQuantity":5,"operator":"=","quantity":0,"unit":"Gram(s)","dailyValueTargetGroup":[{"name":"Infants","operator":"=","percent":0,"footnote":null}],"servingSizeUnit":"Drop(s)"}],"nestedRows":[{"order":3,"ingredientId":283759,"description":"","notes":"","quantity":[{"servingSizeOrder":1,"servingSizeQuantity":5,"operator":"=","quantity":0,"unit":"Gram(s)","dailyValueTargetGroup":[{"name":"Infants","operator":null,"percent":null,"footnote":"Daily Value not established"}],"servingSizeUnit":"Drop(s)"}],"nestedRows":[{"order":4,"ingredientId":283687,"description":"","notes":"","quantity":[{"servingSizeOrder":1,"servingSizeQuantity":5,"operator":"=","quantity":0,"unit":"Gram(s)","dailyValueTargetGroup":[{"name":"Infants","operator":null,"percent":null,"footnote":"Daily Value not established"}],"servingSizeUnit":"Drop(s)"}],"nestedRows":[],"name":"Added Sugars","category":"sugar","ingredientGroup":"Sugar","uniiCode":"0","alternateNames":[],"forms":[]}],"name":"Total Sugars","category":"sugar","ingredientGroup":"Sugar","uniiCode":"1","alternateNames":[],"forms":[]}],"name":"Total Carbohydrates","category":"sugar","ingredientGroup":"Carbohydrate","uniiCode":"0","alternateNames":[],"forms":[]},{"order":5,"ingredientId":197113,"description":"","notes":"Lactobacillus rhamnosus GG (Alt. Name: LGG) Genus: Lactobacillus Species: rhamnosus Note: 1.5 billion CFUs ","quantity":[{"servingSizeOrder":1,"servingSizeQuantity":5,"operator":"=","quantity":0,"unit":"NP","dailyValueTargetGroup":[{"name":"Infants","operator":null,"percent":null,"footnote":"Daily Value not established"}],"servingSizeUnit":"Drop(s)"}],"nestedRows":[],"name":"Lactobacillus rhamnosus GG","category":"bacteria","ingredientGroup":"Lactobacillus rhamnosus","uniiCode":null,"alternateNames":["LGG"],"forms":[]},{"order":6,"ingredientId":197114,"description":"","notes":"","quantity":[{"servingSizeOrder":1,"servingSizeQuantity":5,"operator":"=","quantity":1,"unit":"mg","dailyValueTargetGroup":[{"name":"Infants","operator":null,"percent":null,"footnote":"Daily Value not established"}],"servingSizeUnit":"Drop(s)"}],"nestedRows":[],"name":"German Chamomile flower extract","category":"botanical","ingredientGroup":"German Chamomile ","uniiCode":null,"alternateNames":[],"forms":[]}],"otheringredients":{"text":null,"ingredients":[{"order":1,"ingredientId":4136,"name":"Rice Bran Oil","category":"fat","ingredientGroup":"Rice Oil","uniiCode":null,"alternateNames":[],"forms":[]},{"order":2,"ingredientId":11962,"name":"Carnauba Wax","category":"non-nutrient/non-botanical","ingredientGroup":"Carnauba wax","uniiCode":null,"alternateNames":[],"forms":[]},{"order":3,"ingredientId":282497,"name":"Sucrose","category":"sugar","ingredientGroup":"Sucrose","uniiCode":"C151H8M554","alternateNames":[],"forms":[]},{"order":4,"ingredientId":282516,"name":"Maltodextrin","category":"complex carbohydrate","ingredientGroup":"Maltodextrin","uniiCode":"7CVR7L4A2D","alternateNames":[],"forms":[]},{"order":5,"ingredientId":4158,"name":"Sodium Ascorbate","category":"vitamin","ingredientGroup":"Sodium Ascorbate","uniiCode":null,"alternateNames":[],"forms":[]}]},"offMarket":0,"entryDate":"2020-04-23"}