Stomach Relief Maximum Strength

Stomach Relief Maximum Strength
SPL v2
SPL
SPL Set ID b2d55045-d4a4-4167-a20c-42932f35bab2
Route
ORAL
Published
Effective Date 2019-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1050 mg)
Inactive Ingredients
Benzoic Acid D&c Red No. 22 D&c Red No. 28 Water Saccharin Sodium Salicylic Acid Sodium Salicylate Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-01

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 hour as needed

■ do not exceed 4 doses (120 mL or 8 TBSP) 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

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, xanthan 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   1050 mg

Section 60561-8

Other information

each 30 mL dose cup contains:

■sodium 13 mg, salicylate 455 mg

■ protect from freezing ■ avoid excessive heat

(over 104°F or 40°C) ■ low sodium

Principal Display Panel

MARKET

BASKET ®

"MORE FOR YOUR DOLLAR"

*COMPARE TO

The active ingredient in

PEPTO-BISMOL™ Maximum Strength

Stomach Relief↓

MAXIMUM STRENGTH

Bismuth Subsalicylate

Antidiarrheal / Upset Stomach Reliever

5 Symptom Relief of:

• Nausea           • Upset Stomach

• Heartburn       • Diarrhea

• Indigestion

8 FL OZ (237 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™​.

DISTRIBUTED BY                                                         Made in USA

DEMOULAS SUPERMARKETS INC.                         LR·089 REV01

875 EAST STREET

TEWKSBURY, MA 01876

0   49705 73076   8                                                             PEEL

                                                                                          HERE  

↓Principal Display Label↓

                                              Stomach Relief, Maximum Strength by Market Basket®

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 hour as needed

■ do not exceed 4 doses (120 mL or 8 TBSP) 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

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, xanthan 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   1050 mg

Section 60561-8 (60561-8)

Other information

each 30 mL dose cup contains:

■sodium 13 mg, salicylate 455 mg

■ protect from freezing ■ avoid excessive heat

(over 104°F or 40°C) ■ low sodium

Principal Display Panel

MARKET

BASKET ®

"MORE FOR YOUR DOLLAR"

*COMPARE TO

The active ingredient in

PEPTO-BISMOL™ Maximum Strength

Stomach Relief↓

MAXIMUM STRENGTH

Bismuth Subsalicylate

Antidiarrheal / Upset Stomach Reliever

5 Symptom Relief of:

• Nausea           • Upset Stomach

• Heartburn       • Diarrhea

• Indigestion

8 FL OZ (237 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™​.

DISTRIBUTED BY                                                         Made in USA

DEMOULAS SUPERMARKETS INC.                         LR·089 REV01

875 EAST STREET

TEWKSBURY, MA 01876

0   49705 73076   8                                                             PEEL

                                                                                          HERE  

↓Principal Display Label↓

                                              Stomach Relief, Maximum Strength by Market Basket®

res


Advanced Ingredient Data


Raw Label Data

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