FDA Label for Up And Up Digestive Relief

View Indications, Usage & Precautions

Up And Up 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.

Active Ingredient (In Each 30 Ml Dose Cup)



Bismuth subsalicylate 525 mg


Purposes



Upset stomach reliever and antidiarrheal


Uses



relieves

  • •travelers’ diarrhea
  • •diarrhea
  • •upset stomach due to overindulgence in food and drink, including:
  • •heartburn
  • •indigestion
  • •nausea
  • •gas
  • •belching

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

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

Ask A Doctor Before Use If You Have



  • •fever
  • •mucus in the stool

Ask A Doctor Or Pharmacist Before Use If You Are



taking any drug for

  • •anticoagulation (thinning 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 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 right away (1-800-222-1222).


Directions



  • •shake well before use
  • •for accurate dosing, use dose cup
  • adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed
  • •do not exceed 8 doses (240 mL) 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 30 mL contains: sodium 10 mg
  • salicylate 251 mg
  • •low sodium
  • •sugar free
  • •store at room temperature
  • •protect from freezing
  • •avoid excessive heat (more than over 104°F or 40°C).

Inactive Ingredients



carboxymethylcellulose sodium, D&C red #22, D&C red #28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, Simethicone emulsion, sodium benzoate, sucralose, xanthan gum


Questions?



Call 1-800-910-6874

Safety Sealed: DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN


Principal Display Panel



NDC 11673-706-08

Compare to active ingredient in Pepto-Bismol® Regular Strength*

5-symptom

digestive relief

bismuth subsalicylate 525 mg

upset stomach reliever/antidiarrheal

relieves nausea, heartburn, indigestion, upset stomach and diarrhea

8 FL OZ (236 mL)

Dist. By Target Corp, Mpls , MN 55403

*This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-Bismol® Regular Strength.


* Please review the disclaimer below.