Up And Up 5-symptom Digestive Relief Tablet
FDA Label NDC 11673-122

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Up And Up 5-symptom Digestive Relief (NDC 11673-122). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, reye's syndrome, allergy alert:, otc - do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Tablet)

Bismuth subsalicylate 262 mg

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

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

Otc - Do Not Use

Do not use if you have

  • bloody or black stool
  • an ulcer
  • a bleeding problem

Otc - Ask Doctor

Ask a doctor before use if you have

  • fever
  • mucus in the stool

Otc - Ask Doctor/Pharmacist

Ask a doctor before use if you are taking any drug for

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Otc - When Using

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

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

Other Information

  • each tablets contains: salicylate 102 mg
  • avoid excessive heat (over 104°F or 40°C)

Inactive Ingredients

Flavor, magnesium stearate, microcrystalline cellulose, red# 27 aluminum lake, sorbitol, sucralose.

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 (Pepto 01)

Up & Up Digestive Relief Bismuth Subsalicylate (Pepto 01)

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