FDA Label for Stomach Relief Regular Strength

View Indications, Usage & Precautions

Stomach Relief Regular Strength Product Label

The following document was submitted to the FDA by the labeler of this product Pharmacy Value Alliance, 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.

Other



Drug Facts


Otc - Active Ingredient



Active ingredient 
(in each 30 mL dose cup or 2 tablespoons)
Bismuth subsalicylate 525 mg


Otc - Purpose



Purposes
Upset stomach reliever
and antidiarrheal


Indications & Usage



Uses • relieves. travelers' diarrhea • diarrhea • upset
stomach due to overindulgence of food and drink including:
• heart burn • indigestion • nausea • gas • belching


Warnings



Warnings
Reye's syndrome: Children and teenagers who have or are
recovenng 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.


Other Safety Information



Allergy alert:Contains salicylate. Do not take if you are
• allergic to salicylates (including aspirin)
• taking other salicylate products

Other information • each 30 mL dose
contains: sodium 13 mg, salicylate 256 mg
• protect from freezing
• avoid excessive heat (over 104ο F or 40ο C)
• Low sodium


Otc - Do Not Use



Do not use if you have •an ulcer a bleeding problem
black or bloody stool


Otc - Ask Doctor



Ask a doctor before use if you have
fever  mucus in stool


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist 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
• diarrhea lasts more than 2 days
• symptoms get worse or last more than 2 days
• ringing in the ears or loss of hearing occurs


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 right away.


Dosage & Administration



Directions
• Shake well belore use
• use dose cup or tablespoon (TBSP)
• adults and children 12 years and over: 1 dose
  (30 mL or 2 TBSP) every 1/2 to 1 hour as needed
• do not exceed 8 doses ( 240 mL or 16 TBSP)
  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



Inactive ingredients benzoic acid, D&C red
#22, D&C red # 28, flavor, purified water, saccharin
sodium, salicylic acid, sodium salicylate, xanthan gum


Otc - Questions



Ouestions?  1-877-798-5944.


Principal Display Panel



Premier

Value®

COMPARE TO THE ACTIVE
INGREDIENTS IN
PEPTO BISMOLTM*

STOMACH
RELIEF

Bismuth Subsalicylate
Antidiarrheal / Upset Stomach Reliever

Regular Strength

5 Symptom Relief of:
• Nausea       • Heartburn
• Indigestion • Upset stomach
• Diarrhea

8 FL OZ (237 mL)

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

TAMPER EVIDENT: Do not use if imprinted

shrinkband is missing or broken

*This product is not manufactured or distnbuted by Procter & Gamble,
Inc., the distributor of Pepto-BismolTM.

Distributed By:                                                            Made in USA
Pharmacy Value Alliance, LLC                                              LR-121
407 East Lancaster Avenue,
Wayne, PA 19087

8 40986 03581 4

→DRUG fACTS CONTINUED ON BACK →

8 fl oz pkg.

12 fl oz pkg.

res


* Please review the disclaimer below.