Peptic Relief by Rebel Distributors Corp PEPTIC RELIEF tablet

Peptic Relief by

Drug Labeling and Warnings

Peptic Relief by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PEPTIC RELIEF 
peptic relief tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-639(NDC: 0536-4301)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH SUBSALICYLATE - UNII:62TEY51RR1)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	PINK	Score	no score
Shape	ROUND	Size	18mm
Flavor		Imprint Code	LOGO;045
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-639-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	12/30/2011

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK