STOMACH RELIEF - REGULAR STRENGTH- bismuth subsalicylate liquid

Stomach Relief - Regular Strength by

Drug Labeling and Warnings

Stomach Relief - Regular Strength by is a Otc medication manufactured, distributed, or labeled by AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient
(in each 30 mL dose cup or 2 tablespoons)

Bismuth subsalicylate    525 mg

PURPOSE

Purposes
Bismuth subsalicylate .............. Upset stomach reliever
                                                       and antidiarrheal

INDICATIONS & USAGE

Uses relieves ■ travelers' diarrhea ■ diarrhea
■ upset stomach due to overindulgence of food and drink
including: ■ heart burn ■ indigestion ■ nausea ■ gas
■ belching

WARNINGS

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.

SPL UNCLASSIFIED SECTION

Allergy alert: Contains salicylate. Do not take if you are
■ allergic to salicylates (including aspirin)
■ taking other salicylate products

DO NOT USE

Do not use if you have ■ an ulcer
■ a bleeding problem    ■ black or bloody stool

ASK DOCTOR

Ask a doctor before use if you have
■ fever ■ mucus in stool

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are
taking any drug for ■ anticoagulation (thinning of the blood)
■ diabetes  ■ gout   ■ arthritis

WHEN USING

When using this product a temporary, but harmless,
darkening of the stool and/or tongue may occur

STOP USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, ask health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

Inactive ingredients benzoic acid, D&C red #22,
D&C red # 28, flavor, purified water, saccharin sodium,
salicylic acid, sodium salicylate, xantham gum

QUESTIONS

Questions? 1-877-798-5944

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

                                              Stomach Relief - Regular Strength by AptaPharma Inc.

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INGREDIENTS AND APPEARANCE

STOMACH RELIEF - REGULAR STRENGTH 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-537
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	525 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	pink (color suspension)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76281-537-28	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	10/01/2018

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-537)