Green Relief by Green Choice for Life

Green Relief by

Drug Labeling and Warnings

Green Relief by is a Otc medication manufactured, distributed, or labeled by Green Choice for Life. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GREEN RELIEF- bismuth subsalicylate liquid 
Green Choice for Life

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient (in each 15 mL tablespoon)

Bismuth Subsalicylate 262 mg...............upset stomich reliever and antidiarrheal

upset stomich

anti-diarrheal

Uses

Relieves

• heartburn
• indigestion
• upset stomach
• nausea
• diarrhea

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 doctor before use if you have

• a 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 usung this product a temporary, but harmless, darkening of the stool and/or tounge 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

Directions

Shake well before use

Adults and children 12 years of age and over:

1 dose (2 tablespoons or 30 mL) every 1/2 hour as needed

Do not exceed 8 doses (16 tablespoons or 240 mL) in 24 hours

Use until diarrhea stops, but not more than 2 days

Children under12 years of age: consult a doctor

Drink plenty of water or clear fluids to help prevent dehydration caused by diarrhea

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of oversode or accidental ingestion, get medical help or contact a Poison Control Center right away.

Inactive ingredients

benzoic acid, calendula FE, chamomile FE, D&C yellow #10, FD&C blue #1, kaolin, magnesium aluminum silicate, natural and artificial flavors, peppermint oil, purified water, saccharin sodium, salicylic acid, simethicone, sodium salicylate, sorbic acid, sucralose, xanthan gum

Questions?

Call 305-763-3228 M-F 9 AM - 5 PM Eastern

GREEN RELIEF 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55287-102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55287-102-08	1 in 1 CARTON	02/21/2012	01/01/2020
1		240 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	02/21/2012	01/01/2020

Labeler - Green Choice for Life (828750526)

Revised: 4/2020

Document Id: 35081ff5-f22f-411d-ba1b-e03697f24942

34390-5

Set id: 9f8b1847-d83d-4429-ac15-51419deeba8b

Version: 2

Effective Time: 20200418

 

Green Choice for Life