FDA Label for Stomach Relief

View Indications, Usage & Precautions

Stomach Relief Product Label

The following document was submitted to the FDA by the labeler of this product Consumer Value Products, 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 a doctor
■ drink plenty of clear fluids to help prevent
  dehydration caused by diarrhea


Other Safety Information



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



CVP®

HEALTH

*COMPARE TO
PEPTO-BISMOL®
ACTIVE INGREDIENT

Stomach
Relief

PROTECTIVE COATING ACTION
Bismuth Subsalicylate

SOOTHING RELIEF FOR:

UPSET STOMACH
HEARTBURN
INDIGESTON
NAUSEA
COMMON DIARRHEA

8 FL OZ (237 mL)

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

*This product is not manufactured or distributed by Procter & Gamble,
Inc., the distributor of Pepto-Bismol™.

DISTRIBUTED BY                                                         Made in USA
CONSUMER VALUE PRODUCTS, INC.                    LR-102 REV01
P.O. BOX 6115 TEMPLE, TX 76502

CVPproducts.com

7 61706 16202 6                                                 PEEL

                                                                          HERE

                                        Stomach Relief by Consumer Value Products, Inc.

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* Please review the disclaimer below.