Stomach relief maximum strength liquid

Drug facts

Active ingredient (in each 30 mL dose cup)

Bismuth subsalicylate 1050 mg

Purposes

Upset stomach reliever and antidiarrheal

Uses

relieves

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

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

Do not use if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use ifyou 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

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

Otc - pregnancy or breast feeding section

If pregnant or breast feeding,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 (1-800-222-1222) right away.

Directions

  • shake well before use
  • mL = milliliter
  • measure only with dosing cup provided. Do not use any other dosing device.
  • adults and children 12 years and over: 1 dose (30 mL) every hour as needed
  • do not exceed 4 doses (120 mL) 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 30 mL dose cup contains:magnesium 12 mg, sodium 7 mg
  • salicylate 449 mg
  • sugar free
  • low sodium
  • Store at 20 to 25 C (68 to 77 F) and protect from freezing
  • avoid excessive heat (over 104F or 40C)
  • TAMPER EVIDENT:Do not use if the printed seal under the cap is missing or broken.

Inactive ingredients

benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, magnesium aluminum silicate type 1C, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gum


Questions or comments?

1-855-274-4122

* This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-Bismol TMMax Strength.

Distributed by: Aurohealth LLC.
2572 Brunswick Pike, Lawrenceville, NJ 08648

Ingredients and appearance - Product information

Stomach relief maximum strength liquid- Bismuth subsalicylate

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-301
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Bismuth subsalicylate ( UNII: 62TEY51RR1)( Salicylic acid - UNII: O414PZ4LPZ ) 1050 mgin 30 mL

Inactive Ingredients

Ingredient Name Code
Benzoic acid ( UNII: 8SKN0B0MIM)
Methyl salicylate ( UNII: LAV5U5022Y)
D&c red no. 22 ( UNII: 1678RKX8RT)
D&c red no. 28 ( UNII: 767IP0Y5NH)
Magnesium aluminum silicate type ic ( UNII: XLI9KNX1FT)
Saccharin sodium ( UNII: SB8ZUX40TY)
Salicylic acid ( UNII: O414PZ4LPZ)
Sodium salicylate ( UNII: WIQ1H85SYP)
Sorbic acid ( UNII: X045WJ989B)
Water ( UNII: 059QF0KO0R)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color PINK (Pink to Bright Pink) Flavor WINTERGREEN

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 58602-301-20 236mL in 1 BOTTLE 2017/04/01
2 NDC: 58602-301-16 354mL in 1 BOTTLE 2017/04/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part335 USA 2017/04/01

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 MANUFACTURE( 58602-301)

Package label-principal display panel -8 fl oz (236 ml) bottle

AUROHEALTH
NDC 58602-301-20
Stomach Relief
MAXIMUM STRENGTH
Bismuth Subsalicylate Liquid
Upset Stomach Reliever/Antidiarrheal
Each 30 mL dose of oral solution contains:
1050 mgbismuth subsalicylate
5 Symptom Digestive Relief:

  • Heartburn
  • Indigestion
  • Nausea
  • Upset stomach
  • Diarrhea

*Compare to the active ingredient
in Pepto-Bismol TMMax Strength
Original Flavor
8 FL OZ
(236 mL)