Rapidol Stomach Relief (apta)

SPL v3

SPL

SPL Set ID efba1aea-f468-4f63-e053-2995a90a545b

Route

ORAL

Published

Effective Date 2023-02-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (525 mg)

Inactive Ingredients

Benzoic Acid D&c Red No. 22 D&c Red No. 28 Water Saccharin Sodium Salicylic Acid Sodium Salicylate Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: pink

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2022-12-08 Until 2022-12-08

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

relieves

travelers' diarrhea
diarrhea
upset stomach due to overindulgence of food and drink including:
heart burn
indigestion
nausea
gas
belching

Section 55105-1

Active ingredient (in each 30 mL dose cup or 2 tablespoons)	Purposes
Bismuth subsalicylate 525 mg.................	Upset stomach reliever and antidiarrhea

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

Directions

shake well before use
use dose cup or tablespoon (TBSP)
adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour or every hour as needed
do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours
use until diarrhea stops but not more than 2 days
drink plenty of clear fluids to help prevent dehydration caused by diarrhea
children under 12 years: ask adoctor

Drug Facts

Drug Facts

Questions?

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

Distributed By:

PHARMADEL LLC.

New Castle, DE 19720

Other Information

each 30 mL dose contains: magnesium45 mg, sodium 13 mg, salicylate 256 mg
protect from freezing
avoid excessive heat (over 104ºF or 40ºC)
low sodium

Inactive Ingredients

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

Do Not Use If You Have

an ulcer
a bleeding problem
black or bloody stool

Prinicpal Display Panel

NDC 55758-331-07

Rapidol Stomach Relief 8 FL OZ (237 mL)

When Using This Product

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

Active Ingredient & Purposes

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.

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

Structured Label Content

Uses

relieves

travelers' diarrhea
diarrhea
upset stomach due to overindulgence of food and drink including:
heart burn
indigestion
nausea
gas
belching

Section 55105-1 (55105-1)

Active ingredient (in each 30 mL dose cup or 2 tablespoons)	Purposes
Bismuth subsalicylate 525 mg.................	Upset stomach reliever and antidiarrhea

Warnings

Allergy alert: contains salicylate. Do not take if you are

allergic to salicylates (including aspirin)
taking other salicylate products

Directions

shake well before use
use dose cup or tablespoon (TBSP)
adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour or every hour as needed
do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours
use until diarrhea stops but not more than 2 days
drink plenty of clear fluids to help prevent dehydration caused by diarrhea
children under 12 years: ask adoctor

Drug Facts

Drug Facts

Questions?

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

Distributed By: (Distributed by:)

PHARMADEL LLC.

New Castle, DE 19720

Other Information (Other information)

each 30 mL dose contains: magnesium45 mg, sodium 13 mg, salicylate 256 mg
protect from freezing
avoid excessive heat (over 104ºF or 40ºC)
low sodium

Inactive Ingredients (Inactive ingredients)

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

Do Not Use If You Have (Do not use if you have)

an ulcer
a bleeding problem
black or bloody stool

Prinicpal Display Panel

NDC 55758-331-07

Rapidol Stomach Relief 8 FL OZ (237 mL)

When Using This Product (When using this product)

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

Active Ingredient & Purposes (Active ingredient & Purposes)

Slop Use and Ask A Doctor If (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, (If pregnant or breast feeding,)

ask health professional before use.

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.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are taking any drug for)

anticoagulation (thinning of the blood)
diabetes
gout
arthritis

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "relieves travelers' diarrhea diarrhea upset stomach due to overindulgence of food and drink including: heart burn indigestion nausea gas belching", "55105-1": "Active ingredient (in each 30 mL dose cup or 2 tablespoons) Purposes Bismuth subsalicylate 525 mg................. Upset stomach reliever and antidiarrhea", "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", "Directions": "s hake well before use use dose cup or tablespoon (TBSP) adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour or every hour as needed do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours use until diarrhea stops but not more than 2 days drink plenty of clear fluids to help prevent dehydration caused by diarrhea children under 12 years: ask adoctor", "Drug Facts": "Drug Facts", "Questions?": "1-866-359-3478 (9 AM - 5 PM EST) or pharmadel.com", "Distributed by:": "PHARMADEL LLC. New Castle, DE 19720", "Other information": "each 30 mL dose contains: magnesium45 mg, sodium 13 mg, salicylate 256 mg protect from freezing avoid excessive heat (over 104ºF or 40ºC) low sodium", "Inactive ingredients": "benzoic acid, D&C red #22, D&C red #28, flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, xanthan gum", "Do not use if you have": "an ulcer a bleeding problem black or bloody stool", "Prinicpal Display Panel": "NDC 55758-331-07 Rapidol Stomach Relief 8 FL OZ (237 mL)", "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.", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:27.525600 · Updated: 2026-03-14T23:05:12.885917