Label: PEPTIC RELIEF tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 21695-639-30 - Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 0536-4301
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 30, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
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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
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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.
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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
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
PEPTIC RELIEF
peptic relief tabletProduct 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
