L-Oral STOMACH RELIEF Syrup

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:47:35

Label at a glance#

ProductL-Oral STOMACH RELIEF Syrup
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections

Indications and uses

• Diarrhea • Upset stomach due to overindulgence in food and drink, including: • Heartburn • Indigestion • Nausea • Gas • Belching • Fullness

Dosage and administration

• 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 ...

Storage and handling

• 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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH 15 ML DOSE)

OTC - ACTIVE INGREDIENT SECTION

Bismuth subsalicylate 525 mg

PURPOSE

OTC - PURPOSE SECTION

Upset stomach reliever and Anti-diarrheal

USES

INDICATIONS & USAGE SECTION

• Diarrhea
• Upset stomach due to overindulgence in food and drink, including:
• Heartburn • Indigestion • Nausea • Gas • Belching • Fullness

WARNINGS

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Syrup24Syrup24

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-024-042023-02-08C16284748780-1f386c64a-0167-0266-e053-dadaa90a7c1aL-Oral STOMACH RELIEF SYRUP
73921-024-042023-01-30C16284748780-1f386c64a-0167-0266-e053-dadaa90a7c1aL-Oral STOMACH RELIEF SYRUP

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-02473921-024-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f42bf796-300b-7224-e053-2995a90a7f5ab631eade-43bf-4eb1-a45e-f7e52d6aa6622023-02-08WarningsExact identifier
spl set id: b631eade-43bf-4eb1-a45e-f7e52d6aa662

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.