PEPTIC RELIEF- peptic relief tablet 
Rebel Distributors Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Peptic Relief Drug Facts

Active ingredient

Bismuth Subsalicytate 262mg

Purpose

Anti-diarrheal/Upset stomach reliever

Keep Out of Reach of Children

In case of overdose,, get medical help or contact a Poison Control Center right away.

Uses

* Controls diarrhea

* Relieves upset stomach due to overindulgence in food or drink

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: Do not take if you are

* allergic to salicylates (including aspirin)

* taking other salicylate products

Do not use

* if you have bloody or black stool

* if you have an ulcer or bleeding problem

Ask a doctor before use if you have

* fever

* mucus in the stool

Drug Facts

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

* 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.

Directions

* drink plenty of clear fluids to help prevent dehydration caused by diarrhea

* repeat dosage every 1/2 to 1 hour as needed

* do not take more than 8 doses in 24 hours

* use until diarrhea stops but not more than 2 days

* adults and children 12 years and over:

2 tablets

* children under 12 years: ask a doctor

Other information

* each tablet contains: calcium 77mg

salicylate 102mg

* store at 15°-30°C (59°-86°F)

* protect from moisture

Inactive ingredients

D&C red #27 (al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions or comments?

call 1-800-645-2158, 9 am-5 pm EST, Monday-Friday.

Package/Label Principal Display Panel

Peptic Relief 262mg

PEPTIC RELIEF 
peptic relief tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-639(NDC:0536-4301)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH SUBSALICYLATE - UNII:62TEY51RR1) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 (UNII: 2LRS185U6K)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
DEXTROSE (UNII: IY9XDZ35W2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize18mm
FlavorImprint Code LOGO;045
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21695-639-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33512/30/2011
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 12/2011
Document Id: 39fd1b7e-fac0-4d6f-8bc2-4af6e880a53d
Set id: 39fd1b7e-fac0-4d6f-8bc2-4af6e880a53d
Version: 1
Effective Time: 20111230
 
Rebel Distributors Corp