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| Product NDC Code | 58933-446 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Pepto kids |
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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 | 317865, 701392 |
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| Application Number | M001 | ||||||
| Labeler Name | Procter & Gamble Manufactura S de RL de CV | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Calcium carbonate 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 the right dose on chart below based on weight (preferred), otherwise use age repeat dose as needed do not take more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in a 24-hour period, or use the maximum dosage for more than two weeks, except under the advice and supervision of a doctor. Dosing Chart Weight (lbs.) Age Dose under 24 under 2 yrs ask a doctor 24-47 2-5 yrs 1 tablet 48-95 6-11 yrs 2 tablets
| Weight (lbs.) | Age | Dose |
|---|---|---|
| under 24 | under 2 yrs | ask a doctor |
| 24-47 | 2-5 yrs | 1 tablet |
| 48-95 | 6-11 yrs | 2 tablets |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients D&C Red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, sorbitol, sugar, talc
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 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.Pepto Kids Calcium Carbonate D&C RED NO. 27 ALUMINUM LAKE MAGNESIUM STEARATE MANNITOL POVIDONE SORBITOL SUCROSE TALC CALCIUM CARBONATE CALCIUM CATION CARBONATE ION P
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.PRINCIPAL DISPLAY PANEL - 24 Tablet Carton Pepto ® KIDS CALCIUM CARBONATE/ANTACID CHEWABLES BUBBLE GUM FLAVOR RELIEVES: ACID INDIGESTION HEARTBURN SOUR STOMACH UPSET STOMACH 24 CHEWABLE TABLETS 446
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
TAMPER EVIDENT: Do not use if inner printed seal on bottle is broken or missing.
MADE IN MEXICO DIST. BY PROCTER & GAMBLE, CINCINNATI, OH 45202
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 this and all drugs out of the 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? 1-800-944-9606
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if symptoms last more than two weeks.
Storage and handling
Information about safe storage and handling of the drug product.Other information each tablet contains: calcium 160 mg sodium free Do not exceed 25°C. Preserve in well-closed containers.
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
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