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  5. Label Information: Up And Up 5-symptom Digestive Relief

FDA Label for Up And Up 5-symptom Digestive Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. REYE'S SYNDROME
    6. ALLERGY ALERT:
    7. OTC - DO NOT USE
    8. OTC - ASK DOCTOR
    9. OTC - ASK DOCTOR/PHARMACIST
    10. OTC - WHEN USING
    11. OTC - STOP USE
    12. OTC - PREGNANCY OR BREAST FEEDING
    13. OTC - KEEP OUT OF REACH OF CHILDREN
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. PRINCIPAL DISPLAY PANEL

Up And Up 5-symptom Digestive Relief Product Label

The following document was submitted to the FDA by the labeler of this product Target Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.