Active Ingredient (In Each 30 Ml Dose Cup)
Bismuth subsalicylate 525 mg
Heb Stomach Relief Suspension
FDA Label NDC 37808-607
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Heb Stomach Relief (NDC 37808-607). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 30 ml dose cup), purposes, uses, warnings, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 or 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 at (1-800-222-1222).
Directions
▪ shake well before use▪ Only use dose cup provided▪ adults and children 12 years and over: 1 dose (30 mL) every ½ 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 contains: sodium 10 mg▪ salicylate 261 mg▪ low sodium▪ sugar free▪ store at room temperature▪ protect from freezing▪ avoid excessive heat (more than 104°F or 40°C)
Inactive Ingredients
carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum
Questions Or Comments?
1-866-467-2748
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN.
Principal Display Panel
HEB®
Compare To Pepto-Bismol® Regular Strength active ingredient*
REGULAR STRENGTH
Stomach Relief
Bismuth Subsalicylate 525 mg per 30 mL
UPSET STOMACH RELIEVER/ANTIDIARRHEAL
Multi-Symptom Relief
Relief of:
- Nausea
- Heartburn
- Indigestion
- Upset Stomach
- Diarrhea
Original Flavor
MADE WITH PRIDE & CARE FOR HEB®
SAN ANTONIO, TX 78204
100% GUARANTEE promise
If you aren’t completely pleased with this product, we’ll be happy to replace it or refund your money. You have our word on it.
*This product is not manufactured or distributed by Procter & Gamble, distributor Pepto-Bismol®.
Package Label 473 mL
* Please review the disclaimer below.
