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Product NDC Code | 69676-0060 | ||||
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Drug Name | Childrens tummy relief |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | TABLET, CHEWABLE | ||||
RxCUI drug identifier | 317865 | ||||
Application Number | part331 | ||||
Labeler Name | Genexa Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Calcium carbonate USP 400 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Find right dose on chart below based on weight (preferable); otherwise use age Weight Age Dose over 48 lbs. 6-11 years chew 2 tablets as symptoms occur, not to exceed 6 tablets in 24 hours 24-47 lbs. 2-5 years chew 1 tablet as symptoms occur, not to exceed 3 tablets in 24 hours under 24 lbs. under 2 years ask a doctor
over 48 lbs. | 6-11 years | chew 2 tablets as symptoms occur, not to exceed 6 tablets in 24 hours |
24-47 lbs. | 2-5 years | chew 1 tablet as symptoms occur, not to exceed 3 tablets in 24 hours |
under 24 lbs. | under 2 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients organic beet root, organic carnauba wax, dextose, organic flavors, organic maltodextrin, organic rice bran extract
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms
Purpose
Information about the drug product’s indications for use.Purpose Antacid
Spl product data elements
Usually a list of ingredients in a drug product.Childrens Tummy Relief Calcium carbonate BEET CARNAUBA WAX DEXTROSE MALTODEXTRIN RICE BRAN CALCIUM CARBONATE CARBONATE ION CALCIUM CATION Tan G;strawberry
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Children's Genexa® MEDICINE MADE CLEAN Ages 2-11 Tummy Relief Calcium Carbonate Antacid Heartburn Sour Stomach Acid Indigestion Upset Stomach Compare to active ingredient in Pepto Bismol® Kids Chewable Tablets Bubblegum* How we're different Made without: talc, D&C red no. 27 aluminum lake, sorbitol & more! Organic Berry & Vanilla Flavor 30 Chewable Tablets 23A_Tummy-Relief_Childrens_Carton_R-20220321
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information each tablet contains: elemental calcium 160 mg store between 20-25°C (68-77°F) in a dry place out of direct sunlight
Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing. Patent Pending I Distributed by: Genexa Inc. Atlanta, GA 30318 genexa.com
Made in the USA with globally sourced ingredients R-20220321 NDC 69676-0060-7
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if the child is presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-855-436-3921
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not give the child more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in 24 hours do not give the child the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Ask a doctor or pharmacist before use if the child is presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not give the child more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in 24 hours do not give the child the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor Keep out of reach of children.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API