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Unishield antacid - Medication Information

Product NDC Code 49314-1013
Drug Name

Unishield 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 420 mg/1
Route ORAL
Dosage Form TABLET, CHEWABLE
RxCUI drug identifier 313884
Application Number M001
Labeler Name Unishield
Packages
Package NDC Code Description
49314-1013-3 50 packet in 1 box (49314-1013-3) / 2 tablet, chewable in 1 packet
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Calcium Carbonate 420 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 Adults and children: (12 years and older) Chew 2 tablets every 2 - 3 hours as symptoms occur, repeat hourly if needed. Do not exceed 19 tablets in 24 hours. Children under 12 years: Ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
I nactive ingredients aspartame*, croscarmellose sodium*, gum acacia*, magnesium stearate, maltodextrin, mineral oil*, mint flavor, sorbitol*, sucrose* *may contain

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 ■ acid indigestion ■ sour stomach ■ heartburn ■ 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.
Unishield Antacid Calcium Carbonate ACACIA CALCIUM CARBONATE CALCIUM CATION CARBONATE ION MAGNESIUM STEARATE MALTODEXTRIN SUCROSE FR;8 Peppermint Unishield Antacid Calcium Carbonate MINERAL OIL CALCIUM CARBONATE CALCIUM CATION CARBONATE ION MAGNESIUM STEARATE SORBITOL MALTODEXTRIN ASPARTAME CROSCARMELLOSE SODIUM AZ;036

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.
Unishield Antacid Calcium Carbonate 420 mg 100 Tablets/2 Tablets Per Packet Calcium Rich Chewable Tablets Pull To Open • Relieves upset stomach, and indigestion and heartburn Compare active ingredient to: TUMS® Registered Trademark of McNeil Consumer Healthcare Tamper Evident Unit Dose Packets Unishield Antacid Label 1 Unishield Antacid Calcium Carbonate 420 mg 100 Tablets/2 Tablets Per Packet Calcium Rich Chewable Tablets Pull To Open • Relieves upset stomach, and indigestion and heartburn Compare active ingredient to: TUMS® Registered Trademark of McNeil Consumer Healthcare Tamper Evident Unit Dose Packets Unishield Antacid Label 2

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

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 ■ are taking a prescription drug. Antacids may interact with certain prescription drugs. ■ Have kidney disease

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use ■ the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a doctor

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 the 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 ■calcium content per tablet: 168 mg ■ phenylketonurics: each tablet may contain 1.5 mg phenylalanine ■ store at room temperature 59º-86ºF (15º-30ºC) in a dry place ■ tamper-evident sealed packets ■ do not use any opened or torn packets

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? 1-800-480-5855

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 take more than 19 tablets in a 24 hour period. If symptoms persist for more than 2 weeks, stop using this product and see a doctor.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If 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

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