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 Demoulas Super Markets Inc. 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

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


Otc - Active Ingredient



Active ingredient
(in each 30 mL dose cup or 2 tablespoons)

Bismuth subsalicylate    525 mg


Otc - Purpose



Purposes
Bismuth subsalicylate .............. 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
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.


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



Slop 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 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 before 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 adoctor
■ drink plenty of clear fluids to help prevent dehydration
   caused by diarrhea


Other Safety Information



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


Inactive Ingredient



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


Otc - Questions



Questions? 1-877-798-5944


Principal Display Panel



MARKET
BASKET®
"MORE FOR YOUR DOLLAR"

*COMPARE TO
the active ingredient
in PEPTO-BISMOL

Stomach
Relief
REGULAR STRENGTH

Bismuth Subsalicylate
Antidiarrheal / Upset Stomach Reliever

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

12 FL OZ (354 mL)

TAMPER EVIDENT: Do not use if imprinted
shrinkband is missing or broken

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

Made in USA                 LR-088   REV01
DISTRIBUTED BY
DEMOULAS SUPERMARKETS INC.
875 EAST STREET - TEWKSBURY, MA 01876

0   49705 73077   5

                                              Stomach Relief, Regular Strength by Market Basket®

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* Please review the disclaimer below.