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Childrens antacid - Medication Information

Product NDC Code 55910-590
Drug Name

Childrens antacid

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]
Active Ingredients
Calcium carbonate 400 mg/1
Route ORAL
Dosage Form TABLET, CHEWABLE
RxCUI drug identifier 317865
Application Number M001
Labeler Name DOLGENCORP, LLC
Packages
Package NDC Code Description
55910-590-08 1 bottle, plastic in 1 carton (55910-590-08) / 24 tablet, chewable in 1 bottle, plastic
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each chewable 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 chew or crush tablets completely before swallowing; do not swallow tablets whole repeat dose as needed do not take more than 3 chewable tablets (ages 2-5) or 6 chewable tablets (ages 6-11) in a 24-hour period, or use the maximum dosage of this product for more than two weeks, except under the advice and supervision of a doctor Dosing Chart Weight (lb) Age (yr) Dose (chewable tablets) under 24 under 2 ask a doctor 24-47 2-5 1 tablet 48-95 6-11 2 tablets
Weight (lb)Age (yr)Dose (chewable tablets)
under 24under 2ask a doctor
24-472-51 tablet
48-956-112 tablets

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients acacia, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, maltodextrin, silicon dioxide, sodium lauryl sulfate, sucrose, 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 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 Antacid Calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ACACIA STARCH, CORN D&C RED NO. 27 ALUMINUM LAKE D&C RED NO. 30 FD&C RED NO. 40 MAGNESIUM STEARATE MALTODEXTRIN SILICON DIOXIDE SODIUM LAURYL SULFATE SUCROSE TALC 44;596

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 DG™ | health Compare to active ingredient of Pepto® Kids Chewables* Children's Antacid Calcium Carbonate, 400 mg Chewable Tablets/Antacid Relieves • Acid Indigestion • Heartburn, Sour Stomach • Upset Stomach Chew or crush tablets completely before swallowing. Bubble Gum Flavor 24 Chewable Tablets Actual Tablet Size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Pepto® Kids Chewables. 50844 ORG111959608 DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 Dollar General 44-596A Dollar General 44-596A

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 or comments? 1-888-309-9030

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 store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid excessive humidity see end flap for expiration date and lot number

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. Stop use and ask a doctor if symptoms last more than two weeks. Keep this and all drugs out of the 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