OTC Medication Information: Pink Bismuth

PINK BISMUTH- bismuth subsalicylate liquid
We Care Distributor Inc.

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.

Active ingredient (in each 15 mL)

Bismuth subsalicylate 262 mg

Purposes

Upset stomach reliever/antidiarrheal

Uses

  • relieves upset stomach, heartburn, indigestion, nausea, diarrhea

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

Allergy alert: Contains salicylates. 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 the stool, a sodium-restricted diet, a magnesium restricted diet

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.

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 right away.

Directions

  • Shake well before use
  • Use pre-measured cup for accurate dosing. mL = mililiter
  • Adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed
  • Do not take more than 4 doses 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 15 mL contains: Sodium 24 mg, Sugar free, Magnesium 32 mg
  • Salicylate 159 mg
  • Keep tightly closed
  • Avoid excessive heat (over 104°F or 40°C)
  • protect from freezing
  • store at room temperature
  • TEMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Inactive ingredients

carboxymethylcellulose sodium, D&C red #3, FD&C red #40, flavor, glycerin, magnesium aluminum silicate, saccharin sodium, salicylic acid, sodium benzoate, sodium salicylate, sorbitol, water

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel

Compare to Original Pepto-Bismol® active ingredient

ORIGINAL STRENGTH

Stomach Relief

Upset Stomach Reliever/Antidiarrheal

Bismuth Subsalicylate 262 mg

Protective Coating Action

Soothing Relief for 5 Symptoms:

Heartburn

Indigestion

Upset Stomach

Nausea

Diarrhea

Pink Bismuth
(click image for full-size original)
PINK BISMUTH
bismuth subsalicylate liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70005-047
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISMUTH SUBSALICYLATE (BISMUTH CATION and SALICYLIC ACID) BISMUTH SUBSALICYLATE 262 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
D&C RED NO. 30
FD&C RED NO. 40
GLYCERIN
MAGNESIUM ALUMINUM SILICATE
WATER
SACCHARIN SODIUM
SALICYLIC ACID
SODIUM SALICYLATE
SORBITOL
SODIUM BENZOATE
Product Characteristics
Color PINK (viscous) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70005-047-01 120 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part335 10/25/2016
Labeler — We Care Distributor Inc. (079832998)
Establishment
Name Address ID/FEI Operations
PURINE PHARMA LLC 019950491 manufacture (70005-047)

Revised: 10/2016 We Care Distributor Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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