STOMACH RELIEF- bismuth subsalicylate liquid

STOMACH RELIEF by

Drug Labeling and Warnings

STOMACH RELIEF by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC, GCP Laboratories, GCP LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL Tablespoonful)

Bismuth subsalicylate 262 mg

Purposes

upset stomach reliever and antidiarrheal

Uses

relieves

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

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
• 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 right away.

Directions

• shake well before using

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• for accurate dosing, use dose cup
• adults and children 12 years and over: take 2 tablespoonfuls every ½ to 1 hour as needed
• do not exceed 16 tablespoonfuls in 24 hours
• children under 12 years: ask a doctor

Other information

• each tablespoonful contains: sodium 6 mg, salicylate 130 mg
• low sodium
• sugar free
• protect from freezing
• avoid excessive heat (over 104°F or 40°C)
• visit www.info-xtra.com for health information
• TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken

Inactive ingredients

benzoic acid, flavor, magnesium aluminum silicate, methylcellulose,
purified water, red 22, red 28, saccharin sodium, salicylic acid, simethicone emulsion,
sodium salicylate, sorbic acid, xanthan gum

package Label

INGREDIENTS AND APPEARANCE

STOMACH RELIEF 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-392
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	262 mg  in 15 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 (UNII: 6M3P64V0NC)
METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-392-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2014	11/01/2019
2	NDC: 68016-392-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2014	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	09/01/2014	11/01/2019

Labeler - Chain Drug Consortium, LLC (101668460)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP LABORATORIES		965480861	manufacture(68016-392) , pack(68016-392)