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Up and up 5-symptom digestive relief - Medication Information

Product NDC Code 11673-122
Drug Name

Up and up 5-symptom digestive relief

Type Brand
Pharm Class Bismuth [CS],
Bismuth [EPC]
Active Ingredients
Bismuth subsalicylate 262 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 308760
Application Number M008
Labeler Name Target Corporation
Packages
Package NDC Code Description
11673-122-48 48 tablet in 1 bottle, plastic (11673-122-48)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Bismuth subsalicylate 262 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 • chew or dissolve tablets in mouth • adults and children 12 years and older: 2 caplets every 1/2 to 1 hour as needed • do not exceed 8 doses (16 caplets) in 24 hours • use until diarrhea stops but not more than 2 days • children under 12 years: ask a doctor • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Flavor, magnesium stearate, microcrystalline cellulose, red# 27 aluminum lake, sorbitol, sucralose.

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 • 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 Anti-diarrheal/Upset stomach reliever Uses relieves • traveler’s diarrhea • diarrhea • upset stomach due to overindulgence in food and drink including • heartburn • indigestion • nausea • gas • belching • fullness

Spl product data elements

Usually a list of ingredients in a drug product.
up and up 5-symptom digestive relief Bismuth subsalicylate BISMUTH SUBSALICYLATE BISMUTH CATION SALICYLIC ACID magnesium stearate MICROCRYSTALLINE CELLULOSE D&C RED NO. 27 SORBITOL SUCRALOSE RP124

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 NDC 11673-122-48 Compare to active ingredient in Pepto-Bismol® Chewable Tablets* 5- symptom digestive relief Bismuth subsalicylate, 262 mg/antidiarrheal relief of upset stomach, nausea, heartburn, indigestion, diarrhea 48 TABLETS K PARAVE 48 CHEWABLE TABLETS TAMPER EVIDENT: DO NOT USE IF INDIVIDUAL BLISTER COMPARTMENTS ARE TORN OR OPEN 245 05 0378 R01 ID285492 Dist.by Target Corp., Mpls, MN 55403 ©2015 Target Brands, Inc. Shop Target.com *This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of PEPTO-BISMOL® up & up digestive relief bismuth subsalicylate

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

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 before use 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 out of reach of children. In case of overdose , get medical help or contact a Poison Control Center immediately.1-800-222-1222.

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 or last more than 2 days • ringing in the ears occurs 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, but harmless, darkening of the stool and/or tongue may occur.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast feeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information • each tablets contains: salicylate 102 mg • avoid excessive heat (over 104°F or 40°C)

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 before use if you are taking any drug for • anticoagulation (thinning of the blood) • diabetes • gout • arthritis When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. Stop use and ask a doctor if • symptoms get worse or last more than 2 days • ringing in the ears occurs or loss of hearing occurs • diarrhea lasts more than 2 days If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center immediately.1-800-222-1222.

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