L-Oral STOMACH RELIEF SYRUP

L-Oral STOMACH RELIEF Syrup by

Drug Labeling and Warnings

L-Oral STOMACH RELIEF Syrup by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

L-ORAL STOMACH RELIEF SYRUP- bismuth subsalicylate syrup 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

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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L-Oral STOMACH RELIEF SYRUP

DRUG FACTS

ACTIVE INGREDIENT (IN EACH 15 ML DOSE)

Bismuth subsalicylate 525 mg

PURPOSE

Upset stomach reliever and Anti-diarrheal

USES

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 right away.

DIRECTIONS

Shake well before use Only use dose cup provided

 Adults and children 12 years and over: 15 mL (1 dose) every ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea 15mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) 

 Do not exceed 8 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 contains: magnesium 3 mg, sodium 2 mg Salicylate 230 mg 

 Low sodium Protect from freezing Avoid excessive heat (over 104°F or 40°C)

TAMPER EVIDENT: Do not use if printed shrink band is missing or broken.

INACTIVE INGREDIENTS

Benzoic acid, D&C Red No. 22, D&C Red No. 28, Flavor, Gellan gum, Magnesium aluminum silicate, Methylcellulose, Salicylic acid, Sodium salicylate, Sorbic acid, Sucralose, Water.

QUESTIONS OR COMMENTS?

Call toll-free 1-800-572-6632, weekdays, 7:00 AM - 5:30 PM EST

Anti-diarrheal / Upset stomach reliever

Symptom Relief:   Upset Stomach  Diarrhea  Indigestion  Heartburn  Nausea

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

Syrup24

L-ORAL STOMACH RELIEF SYRUP 
bismuth subsalicylate syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73921-024
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBIC ACID (UNII: X045WJ989B)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73921-024-041 in 1 CARTON04/01/202102/08/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33504/01/202102/08/2023
Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)
Establishment
NameAddressID/FEIBusiness Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED860186917manufacture(73921-024)

Revised: 2/2023
 

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