Orange & Creme Multi-symptom

Orange & Creme Multi-symptom
SPL v1
SPL
SPL Set ID 29bb35d4-11e3-ec6d-e063-6394a90ab412
Route
ORAL
Published
Effective Date 2025-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Starch, Corn Magnesium Stearate Sucrose Calcium Carbonate

Identifiers & Packaging

Pill Appearance
Imprint: W;304 Shape: round Color: white Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-01

Description

Drug Facts

Purpose

Upset stomach reliever and anttidiarrheal


Medication Information

Purpose

Upset stomach reliever and anttidiarrheal

Description

Drug Facts

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness
Section 42229-5

Drug Facts

Purposes

Upset stomach reliever and anttidiarrheal

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 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
  • chew or crush tablets completely before swallowing. Do not swallow tablets whole.
  • adults and children 12 years of age and over:
  • for diarrhea: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed
  • for overindulgence (upset stomach, heartburn, indigestion, nausea): 2 tablets (1 dose) every 1/2 hour as needed
  • do not exceed 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years of age: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Do Not Use If

you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Other Information
  • each tablet contains: calcium 65 mg, salicylate 102 mg
  • avoid excessive heat (over 104°F or 40°C)
  • do not use if safety seal on carton printed with "SEALED FOR YOUR SAFETY" is torn or missing
  • read and keep outer carton for full warnings and directions
Inactive Ingredients

calcium carbonate, corn starch, natural flavors, sucrose, vegetable magnesium stearate

Questions Or Comments?

Call 1-512-551-9770

Principal Display Panel

CLEAN MEDICINE

No Dyes, No Artificial Sweeteners, Non-GMO, No Talc, No Titanium Dioxide

WONDERBELLY

Multi-Symptom

Bismuth Subsalicylate 262 mg

Upset Stomach

Nausea

Indigestion

Diarrhea

Fullness

ORANGE 7 CRÈME

Flavor

48 Chewable Tablets

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
If Pregnant Or Breastfeeding,

ask a 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.

Active Ingredient (in Each Tablet)

Bismuth subsalicylate 262 mg

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 the blood)
  • diabetes
  • gout
  • arthritis

Structured Label Content

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness
Section 42229-5 (42229-5)

Drug Facts

Purposes

Upset stomach reliever and anttidiarrheal

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 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
  • chew or crush tablets completely before swallowing. Do not swallow tablets whole.
  • adults and children 12 years of age and over:
  • for diarrhea: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed
  • for overindulgence (upset stomach, heartburn, indigestion, nausea): 2 tablets (1 dose) every 1/2 hour as needed
  • do not exceed 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years of age: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Do Not Use If (Do not use if)

you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Other Information (Other information)
  • each tablet contains: calcium 65 mg, salicylate 102 mg
  • avoid excessive heat (over 104°F or 40°C)
  • do not use if safety seal on carton printed with "SEALED FOR YOUR SAFETY" is torn or missing
  • read and keep outer carton for full warnings and directions
Inactive Ingredients (Inactive ingredients)

calcium carbonate, corn starch, natural flavors, sucrose, vegetable magnesium stearate

Questions Or Comments? (Questions or comments?)

Call 1-512-551-9770

Principal Display Panel

CLEAN MEDICINE

No Dyes, No Artificial Sweeteners, Non-GMO, No Talc, No Titanium Dioxide

WONDERBELLY

Multi-Symptom

Bismuth Subsalicylate 262 mg

Upset Stomach

Nausea

Indigestion

Diarrhea

Fullness

ORANGE 7 CRÈME

Flavor

48 Chewable Tablets

Stop Use and Ask A Doctor If (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
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a 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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Bismuth subsalicylate 262 mg

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 the blood)
  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)