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Moore medical bismuth - Medication Information

Product NDC Code 55670-474
Drug Name

Moore medical bismuth

Type Brand
Active Ingredients
Bismuth subsalicylate 262 mg/1
Route ORAL
Dosage Form TABLET, CHEWABLE
RxCUI drug identifier 308761
Application Number part335
Labeler Name Moore Medical LLC
Packages
Package NDC Code Description
55670-474-47 100 packet in 1 box (55670-474-47) / 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) Bismuth Subsalicylate 262mg (each tablet contains 102 mg salicylate)

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 ■ do not use more than directed ■ chew or crush tablets completely before swallowing ■ do not swallow tablets whole ■ use until diarrhea stops but not more than 2 days ■ drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea ■ do not exceed 16 tablets in 24 hours Adults and children: (12 years and older) Take 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed Children under 12 years: Do not give to children under 12 years of age.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients acacia gum, aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon 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 Temporarily relieves ■ traveler’s diarrhea ■ diarrhea ■ upset stomach due to overindulgence in food and drink, including: ■ heartburn ■ indigestion ■ nausea ■ gas ■ belching ■ fullness

Purpose

Information about the drug product’s indications for use.
Purpose Upset stomach reliever/antidiarrheal

Spl product data elements

Usually a list of ingredients in a drug product.
Moore Medical Bismuth BISMUTH SUBSALICYLATE ACACIA MALTODEXTRIN ASPARTAME CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE D&C RED NO. 27 DEXTRATES MAGNESIUM STEARATE SILICON DIOXIDE BISMUTH SUBSALICYLATE SALICYLIC ACID BISMUTH CATION RH;046

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.
Moore Medical Bismuth Label moore medical Supporting Health and Care Reorder No. 82473 UPN# 0-0607415-82473-5 Moore Brand® Bismuth Tablets 100 Packets/2 Tablets Controls diarrhea within 24 hours, relieving associated abdominal cramps; provides soothing relief for: indigestion, upset stomach, heartburn and nausea. Bismuth Subsalicylate 262 mg Chew or crush tablets completely before swallowing. Do not swallow tablets whole. To Reorder: Call: 800.234.1464 Fax: 800.944.6667 Online: www.mooremedical.com Moore

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 phenylketonurics: contains phenylalanine 1.1mg per tablet each tablet contains 73mg elemental calcium store at room temperature 59º-86ºF (15º-30ºC) tamper-evident sealed packets do not use any opened or torn packets

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have fever mucus in the stool

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 if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis

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 if you have bloody or black stool an ulcer a bleeding problem

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 reach of children. In case of accidental overdose, contact a physician or poison control center immediately.

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? Call 800.234.1464

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 get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days

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 a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena.

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 Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome a rare but serious illness. Allergy alert: Contains salicylate. Do not take if you are: allergic to salicylates (including aspirin) taking other salicylate products Do not use if you have bloody or black stool an ulcer a bleeding problem Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis Stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena. If pregnant or breast-feeding , ask a health professional before use. Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately.

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