Stomach Relief by Aurohealth LLC STOMACH RELIEF liquid

Stomach Relief by

Drug Labeling and Warnings

Stomach Relief by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each 30 mL dose cup)

Bismuth subsalicylate 525 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
  • fullness

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 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

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

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 1/2 to 1 hour as needed
• do not exceed 8 doses (240 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 233 mg
• low sodium
• Store at 20° to 25°C (68° to 77°F)and protect from freezing
• avoid excessive heat (over 104°F or 40°C)

• 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-BismolTM.

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (236 mL) Bottle

AUROHEALTH
NDC: 58602-302-20
Stomach Relief
Bismuth Subsalicylate Liquid
Upset Stomach Reliever/
Antidiarrheal
Each 30 mL dose of oral solution contains:
525 mg - Bismuth subsalicylate
5 Symptom Digestive Relief:

• Heartburn
• Indigestion
• Nausea
• Upset stomach
• Diarrhea

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

INGREDIENTS AND APPEARANCE

STOMACH RELIEF 
stomach relief liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-302
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	525 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
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)	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-302-20	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2017
2	NDC: 58602-302-16	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2017
3	NDC: 58602-302-26	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part335	04/01/2017

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-302)