Peptic Relief by Chain Drug Consortium, LLC Drug Facts

Peptic Relief by

Drug Labeling and Warnings

Peptic Relief by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PEPTIC RELIEF- bismuth subsalicylate suspension 
Chain Drug Consortium, LLC

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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Drug Facts

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 or vomiting occur, consult a
doctor because these symptoms could be an early sign of
Reye’s syndrome, a rare but serious illness.

Allergy alert: Contains salicylate.


Do not take if you are: taking other salicylate products
allergic to salicylates (including aspirin)

Do not use if you have

an ulcer a bleeding problem bloody or black stool

Ask a doctor before use if you have

fever mucus in stool

Ask a doctor or pharmacist before use if you are taking any drug for

anticoagulation (thinning 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.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, seek professional
assistance or contact a Poison Control Center
immediately.

Directions

Directions shake well before use
for accurate dosing, use dose cup
adults and children 12 years and over:
1 dose (2 tablespoons or 30 ml) every 1/2 to 1 hour
as needed
do not exceed 8 doses
(16 tablespoons or 240 ml) 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 Information

each tablespoon contains: sodium 6 mg
sugar free low sodium keep tightly closed
avoid excessive heat (over 104˚F or 40˚C)
protect from freezing.
Total salicylate per tablespoon...........................130 mg
Visit www.peptic-drug-facts.com

Inactive Ingredients

benzoic acid, flavor, magnesium aluminum silicate, methyl cellulose, purified
water, red 22, red 28, saccharin sodium, salicylic acid,
sodium salicylate, sorbic acid

Uses

relieves upset stomach heartburn
indigestion diarrhea nausea

Active Ingredients

Bismuth subsalicylate 262 mg

Purpose

Bismuth subsalicylate....................upset stomach reliever/antidiarrheal

Principal Display Panel

Premier Value

Regular Strength Pink bismuth

compare to the active ingredient in Regular Strength Pepto Bismol

Soothing Relief for Upset stomach, indigestion, heartburn, nausea, diarrhea

16 fl oz (473 mL)


image of label
PEPTIC RELIEF 
bismuth subsalicylate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68016-016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBIC ACID (UNII: X045WJ989B)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68016-016-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/13/200912/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33508/13/200912/31/2019
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 12/2018