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Product NDC Code | 37808-063 | ||||||
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Drug Name | Assorted fruit panned chew |
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Type | Brand | ||||||
Pharm Class | Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA] |
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Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | TABLET, CHEWABLE | ||||||
RxCUI drug identifier | 308915 | ||||||
Application Number | M001 | ||||||
Labeler Name | HEB | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each chew) Calcium Carbonate 750mg
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 Adults and children 12 years and older chew and swallow 1 to 2 chews every 2-4 hours as needed. Do not exceed 5 chews in 24-hours. Children under 12 years consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 lake (tartrazine), FD&C yellow no. 6, FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, medium chain triglycerides, methyl paraben, modified corn starch, natural and artificial flavors, pregelatinized corn starch, propylene glycol, propyl paraben, phosphoric acid, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose and titanium dioxide.
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 Sour stomach Acid indigestion Upset stomach due to 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.Assorted Fruit panned chew Calcium Carbonate CARNAUBA WAX CALCIUM CARBONATE CALCIUM CATION FC
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.HEB Antacid Fruit Chews 120ct
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 you are now taking a prescription drug. Antacids may interact with certain prescription drugs. Do not take more than 5 chews in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. When using this product constipation may occur.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Each chew contains: calcium 300 mg, magnesium 1mg Contains soy Contains FD&C yellow no. 5 (tartrazine) as a color additive Store between 20º to 25ºC (68º to 77ºF) in a dry place
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions: Or to report an adverse event call 1-800-245-2898 Monday - Friday, 9AM - 4PM EST
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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 Do not use if you have ever had an allergic reaction to this product or any of its ingredients
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