family wellness stomach relief cherry

family wellness stomach relief cherry
SPL v1
SPL
SPL Set ID 16cca659-33e9-42b1-ad7e-583f4a9a2fd5
Route
oral
Published
Effective Date 2024-02-13
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (262 mg)
Inactive Ingredients
calcium carbonate d&c red no. 27 magnesium stearate mannitol starch, corn saccharin sodium adipic acid fd&c red no. 40 povidone

Identifiers & Packaging

Pill Appearance
Imprint: G122 Shape: round Color: pink Size: 16 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-02-13

Purpose

Upset stomach reliever and anti-diarrheal

Description

Bismuth subsalicylate 262 mg (total salicylate 102 mg per tablet)


Medication Information

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 behaviour 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




Purpose

Upset stomach reliever and anti-diarrheal

Directions
  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration caused by diarrhea
Other Information
  • each tablet contains:
  • sodium less than 1 mg
  • salicylate 102 mg
  • very low sodium
  • avoid excessive heat (over 104oF or 40oC)
  • TAMPER EVIDENT: Do not use if individual compartments are torn or open
Inactive Ingredients

adipic acid, calcium carbonate, D&C red 27 aluminum lake, FD&C red # 40 aluminum lake, flavors, magnesium stearate, mannitol, povidone, pregelatinized starch, saccharin sodium

Description

Bismuth subsalicylate 262 mg (total salicylate 102 mg per tablet)

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN PEPTO-BISMOL®*



Family Wellness

Stomach Relief


Bismuth Subsalicylate, 262 mg-Anti-diarrheal

RELIEVES 5 MAJOR SYMPTOMS:

  • Heartburn
  • Indigestion
  • Upset stomach
  • Diarrhea
  • Nausea


Cherry Flavor

30 CHEWABLE TABLETS

NDC 55319-122-49



Use(s)

relieves:



  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms
Do Not Use If You Have
  • bloody or black stool
  • an ulcer
  • a bleeding problem
When Using This Product

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

Stop Use and Ask Doctor If
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient(in Each Tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the 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

Warnings (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 behaviour 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




Purpose (PURPOSE)

Upset stomach reliever and anti-diarrheal

Directions (DIRECTIONS)
  • chew or dissolve in mouth
  • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
  • do not take more than 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration caused by diarrhea
Other Information (OTHER INFORMATION)
  • each tablet contains:
  • sodium less than 1 mg
  • salicylate 102 mg
  • very low sodium
  • avoid excessive heat (over 104oF or 40oC)
  • TAMPER EVIDENT: Do not use if individual compartments are torn or open
Inactive Ingredients (INACTIVE INGREDIENTS)

adipic acid, calcium carbonate, D&C red 27 aluminum lake, FD&C red # 40 aluminum lake, flavors, magnesium stearate, mannitol, povidone, pregelatinized starch, saccharin sodium

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO THE ACTIVE INGREDIENT IN PEPTO-BISMOL®*



Family Wellness

Stomach Relief


Bismuth Subsalicylate, 262 mg-Anti-diarrheal

RELIEVES 5 MAJOR SYMPTOMS:

  • Heartburn
  • Indigestion
  • Upset stomach
  • Diarrhea
  • Nausea


Cherry Flavor

30 CHEWABLE TABLETS

NDC 55319-122-49



Use(s) (USE(S))

relieves:



  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms
Do Not Use If You Have (DO NOT USE IF YOU HAVE)
  • bloody or black stool
  • an ulcer
  • a bleeding problem
When Using This Product (WHEN USING THIS PRODUCT)

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

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
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 immediately.

If Pregnant Or Breast Feeding, (IF PREGNANT OR BREAST-FEEDING,)

ask a health professional before use.

Active Ingredient(in Each Tablet) (ACTIVE INGREDIENT(in each tablet))

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)
  • fever
  • mucus in the stool
Ask A Doctor Or Pharmacist Before Use If You Are (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


Raw Label Data

All Sections (JSON)