Stomach Relief - Regular Strength
970b4118-2c2e-4806-8fe8-937ba06cf6e9
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Warnings and Precautions
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.
Indications and Usage
Uses
relieves ■ travelers' diarrhea ■ diarrhea
■ upset stomach due to overindulgence of food and drink
including: ■ heart burn ■ indigestion ■ nausea ■ gas
■ belching
Dosage and Administration
Directions.
Shake well before use
■ use dose cup or tablespoon (TBSP)
■ adults and children 12 years and over: 1 dose (30 mL or 2
TBSP) every 1/2 to 1 hour as needed
■ do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours
■ use until diarrhea stops but not more than 2 days
■ children under 12 years: ask adoctor
■ drink plenty of clear fluids to help prevent dehydration
caused by diarrhea
Description
Drug Facts
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right away.
Section 50566-9
Slop use and ask a doctor if
■ diarrhea lasts more than 2 days
■ symptoms get worse or last more than 2 days
■ ringing in the ears or loss of hearing occurs
Section 50567-7
When using this product a temporary, but harmless,
darkening of the stool and/or tongue may occur
Section 50568-5
Ask a doctor or pharmacist before use if you are
taking any drug for ■ anticoagulation (thinning of the blood)
■ diabetes ■ gout ■ arthritis
Section 50569-3
Ask a doctor before use if you have
■ fever ■ mucus in stool
Section 50570-1
Do not use if you have ■ an ulcer
■ a bleeding problem ■ black or bloody stool
Section 51727-6
Inactive ingredients
benzoic acid, D&C red #22,
D&C red # 28, flavor, purified water, saccharin sodium,
salicylic acid, sodium salicylate, xantham gum
Section 53413-1
Questions? 1-877-798-5944
Section 53414-9
If pregnant or breast feeding, ask health professional before use.
Section 55105-1
Purposes
Bismuth subsalicylate .............. Upset stomach reliever
and antidiarrheal
Section 55106-9
Active ingredient
(in each 30 mL dose cup or 2 tablespoons)
Bismuth subsalicylate 525 mg
Section 60561-8
Other information
■ each 30 mL dose cup contains: sodium 13 mg, salicylate 256 mg
■ protect from freezing ■ avoid excessive heat (over 104ºF or 40ºC)
■ Low sodium
Principal Display Panel
AP SAFE NDC 76281-537-28
*COMPARE TO
the active ingredient in
PEPTO-BISMOL™
Stomach
Relief
Bismuth Subsalicylate
Antidiarrheal / Upset Stomach Reliever
Regular Strength
5 Symptom Relief of:
● Nausea ● Heartburn ●Indigestion
● Upset stomach ● Diarrhea
12 FL OZ (354 mL)
TAMPER EVIDENT: Do not use if imprinted
shrinkband is missing or broken
*This product is not manufactured or distributed by
Procter & Gamble, Inc., the distributor of Pepto-Bismol™.
Made in USA AP-LR-11 REV01
Manufactured by: AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110
3 76281 53728 4
12 OZ
6 OZ
Stomach Relief - Regular Strength by AptaPharma Inc.
res
Structured Label Content
Indications and Usage (34067-9)
Uses
relieves ■ travelers' diarrhea ■ diarrhea
■ upset stomach due to overindulgence of food and drink
including: ■ heart burn ■ indigestion ■ nausea ■ gas
■ belching
Dosage and Administration (34068-7)
Directions.
Shake well before use
■ use dose cup or tablespoon (TBSP)
■ adults and children 12 years and over: 1 dose (30 mL or 2
TBSP) every 1/2 to 1 hour as needed
■ do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours
■ use until diarrhea stops but not more than 2 days
■ children under 12 years: ask adoctor
■ drink plenty of clear fluids to help prevent dehydration
caused by diarrhea
Warnings and Precautions (34071-1)
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.
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
Slop use and ask a doctor if
■ diarrhea lasts more than 2 days
■ symptoms get worse or last more than 2 days
■ ringing in the ears or loss of hearing occurs
Section 50567-7 (50567-7)
When using this product a temporary, but harmless,
darkening of the stool and/or tongue may occur
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are
taking any drug for ■ anticoagulation (thinning of the blood)
■ diabetes ■ gout ■ arthritis
Section 50569-3 (50569-3)
Ask a doctor before use if you have
■ fever ■ mucus in stool
Section 50570-1 (50570-1)
Do not use if you have ■ an ulcer
■ a bleeding problem ■ black or bloody stool
Section 51727-6 (51727-6)
Inactive ingredients
benzoic acid, D&C red #22,
D&C red # 28, flavor, purified water, saccharin sodium,
salicylic acid, sodium salicylate, xantham gum
Section 53413-1 (53413-1)
Questions? 1-877-798-5944
Section 53414-9 (53414-9)
If pregnant or breast feeding, ask health professional before use.
Section 55105-1 (55105-1)
Purposes
Bismuth subsalicylate .............. Upset stomach reliever
and antidiarrheal
Section 55106-9 (55106-9)
Active ingredient
(in each 30 mL dose cup or 2 tablespoons)
Bismuth subsalicylate 525 mg
Section 60561-8 (60561-8)
Other information
■ each 30 mL dose cup contains: sodium 13 mg, salicylate 256 mg
■ protect from freezing ■ avoid excessive heat (over 104ºF or 40ºC)
■ Low sodium
Principal Display Panel
AP SAFE NDC 76281-537-28
*COMPARE TO
the active ingredient in
PEPTO-BISMOL™
Stomach
Relief
Bismuth Subsalicylate
Antidiarrheal / Upset Stomach Reliever
Regular Strength
5 Symptom Relief of:
● Nausea ● Heartburn ●Indigestion
● Upset stomach ● Diarrhea
12 FL OZ (354 mL)
TAMPER EVIDENT: Do not use if imprinted
shrinkband is missing or broken
*This product is not manufactured or distributed by
Procter & Gamble, Inc., the distributor of Pepto-Bismol™.
Made in USA AP-LR-11 REV01
Manufactured by: AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110
3 76281 53728 4
12 OZ
6 OZ
Stomach Relief - Regular Strength by AptaPharma Inc.
res
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Source: dailymed · Ingested: 2026-02-15T12:02:37.293858 · Updated: 2026-03-14T23:02:16.200124