Nexmed Multi Symptom Stomach Relief Capsule, Liquid Filled
FDA Label NDC 83059-0092

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Nexmed Multi Symptom Stomach Relief (NDC 83059-0092). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient (in each softgel), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Softgel)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever
and anti-diarrheal

Uses

relieves:

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea 
  • gas
  • belching
  • fullness

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:Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

Otc - Do Not Use

Do not use if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Otc - Ask Doctor

Ask a doctor before use if you have

  • fever
  • mucus in the stool

Otc - Ask Doctor/Pharmacist

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

  • anticoagulation (thinning 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

Stop use and ask a doctor if

  • symptoms get worse or last more than 2 days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a 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 (1-800-222-1222).

Directions

  • swallow with water, do not chew
  • adults and children 12 years and over:
  • 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea
  • 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 softgels) 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
  • take preferably at bedtime or as directed by a doctor

Other Information

  • each softgel contains:salicylate 99 mg
  • very low sodium 
  • store between 20-25° C (68-77° F)

Inactive Ingredients

FD&C red #33, FD&C yellow #6, gelatin, glycerin, lecithin, polyethylene glycol-400, polysorbate 20, polysorbate 80, povidone, purified water, sorbitan, sorbitol solution*, titanium dioxide *may contain these ingredients

Questions Or Comments?

1-800-373-6981

Other

Distributed by:

nexmed

Holbrook, NY 11741

Principal Display

multi-symptom

stomach relief

* Please review the disclaimer below.