STOMACH RELIEF REGULAR STRENGTH- bismuth subsalicylate suspension

STOMACH RELIEF by

Drug Labeling and Warnings

STOMACH RELIEF by is a Otc medication manufactured, distributed, or labeled by Pharmacy Value Alliance, LLC, 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
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
recovenng 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.

OTHER SAFETY INFORMATION

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

Stop 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 a 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 belore 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 a doctor
drink plenty of clear fluids to help prevent
  dehydration caused by diarrhea

OTHER SAFETY INFORMATION

Other information each 30 mL dose
contains: sodium 13 mg, salicylate 256 mg
protect from freezing
avoid excessive heat (over 104ο F or 40ο C)
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, xanthan gum

QUESTIONS

Ouestions?  1-877-798-5944.

Principal Display Panel

Premier

Value®

COMPARE TO THE ACTIVE
INGREDIENTS IN
PEPTO BISMOLTM*

STOMACH
RELIEF

Bismuth Subsalicylate
Antidiarrheal / Upset Stomach Reliever

Regular Strength

5 Symptom Relief of:
Nausea        Heartburn
Indigestion  Upset stomach
Diarrhea

8 FL OZ (237 mL)

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

TAMPER EVIDENT: Do not use if imprinted

shrinkband is missing or broken

*This product is not manufactured or distnbuted by Procter & Gamble,
Inc., the distributor of Pepto-BismolTM.

Distributed By:                                                            Made in USA
Pharmacy Value Alliance, LLC                                              LR-121
407 East Lancaster Avenue,
Wayne, PA 19087

8 40986 03581 4

→DRUG fACTS CONTINUED ON BACK →

8 fl oz pkg.

12 fl oz pkg.

res

INGREDIENTS AND APPEARANCE

STOMACH RELIEF  REGULAR STRENGTH
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-557
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	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-557-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2019
2	NDC: 68016-557-12	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	12/17/2019

Labeler - Pharmacy Value Alliance, LLC (101668460)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(68016-557)