FDA Label for Stomach Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 30 ML DOSE )
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDEN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Stomach Relief Product Label
The following document was submitted to the FDA by the labeler of this product Pai Holdings, Llc. 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 )
Bismuth subsalicylate 525 mg
Purpose
Upset stomach reliever/Antidiarrheal
Uses
relieves
- diarrhea
- travelers' diarrhea
- upset stomach due to overindulgence in food and drink, including:
- heartburn
- gas
- indigestion
- nausea
- fullness
- 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
- diabetes
- gout
- arthritis
- anticoagulation (thinning the blood)
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 Childen.
In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away.
Directions
- mL = milliliter
- shake well before using
- only use dose ready dosing cup provided. Do not use any other dosing device
- adults and children 12 years and over:
- 30 mL (1 dose) every 1/2 hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
- 30 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (240 mL ) in 24 hours
- use until diarrhea stop but not more than 2 days
- children under 12 years of age: ask a doctor
- drink plenty of clear fluids to help prevent dehydration cause by diarrhea
Other Information
- each 30 mL contains: potassium 8 mg, sodium 9 mg
- each 30 mL contains: salicylate 206 mg
- low sodium
- protect from freezing
- avoid excessive heat (over 104°F or 40°C)
- supplied in the following oral dosage forms
NDC 0121-0910-30: 30 mL unit dose cup, in a tray of ten cups.
Inactive Ingredients
benzoic acid, D&C red #22, D&C red #28, flavor, glycerin, purified water, sucralose, xanthan gum
Questions Or Comments?
Call 1-800-845-8210.
PACKAGED BY:
Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com
R06/20
Principal Display Panel
Delievers 30 mL
NDC 0121-0910-30
Bismuth Subsalicylate
525 mg/30 mL
Upset stomach reliever/Antidiarrheal
FOR INSTITUTIONAL USE ONLY
* Please review the disclaimer below.