Stomach Relief - Regular Strength

Stomach Relief - Regular Strength
SPL v5
SPL
SPL Set ID 970b4118-2c2e-4806-8fe8-937ba06cf6e9
Route
ORAL
Published
Effective Date 2020-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (525 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 1/2 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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