RAPIDOL STOMACH RELIEF- bismuth subsalicylate liquid 
Pharmadel 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.

----------

Rapidol Stomach Relief (APTA)

Drug Facts

Drug Facts

Active ingredient & Purposes

Active ingredient
(in each 30 mL dose cup or 2 tablespoons)

Purposes
Bismuth subsalicylate 525 mg.................Upset stomach reliever and antidiarrhea

Uses

relieves

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

Do not use if you have

  • an ulcer
  • a bleeding problem
  • black or bloody 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 of the blood)
  • diabetes
  • gout
  • arthritis

When using this product

a temporary, but harmless, darkening of the stool and/or tongue may occur.

Slop use and ask a doctor if

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

If pregnant or breast feeding,

ask health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions



Other information

Inactive ingredients

benzoic acid, D&C red #22, D&C red #28, flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, xanthan gum

Questions?

1-866-359-3478 (9 AM - 5 PM EST) or pharmadel.com

Distributed by:

PHARMADEL LLC.

New Castle, DE 19720

Prinicpal Display Panel

NDC 55758-331-07

Rapidol Stomach Relief 8 FL OZ (237 mL)

Rapidol Stomach Relief PDP

RAPIDOL STOMACH RELIEF 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-331
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorpink (color suspension) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-331-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product12/08/202212/08/2022
2NDC:55758-331-07237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33512/08/2022
Labeler - Pharmadel LLC (030129680)

Revised: 2/2023
Document Id: f4221c43-4a3e-e4ad-e053-2995a90a3095
Set id: efba1aea-f468-4f63-e053-2995a90a545b
Version: 2
Effective Time: 20230207
 
Pharmadel LLC