Label: STOMACH RELIEF- bismuth subsalicylate tablet, chewable
- NDC Code(s): 55301-319-01
- Packager: ARMY AND AIR FORCE EXCHANGE SERVICE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated February 25, 2017
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- Active ingredient (in each tablet)
Bismuth subsalicylate 262 mgClose
Upset stomach reliever/antidiarrhealClose
- travelers' diarrhea
- upset stomach due to overindulgence in food and drink, including:
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.
Allergy alert: Contains salicylate. Do not take if you are:
- allergic to salicylates (including aspirin)
- taking other salicylate products
Ask a doctor or pharmacist before use if you are
taking any drug for
- anticoagulation (thinning the blood)
Stop use and ask a doctor if
- symptoms get worse or last more than 2 days
- ringing in the ears or loss of hearing occurs
- diarrhea lasts more than 2 days
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- chew or dissolve in mouth
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed. Do not exceed 8 doses (16 tablets) in 24 hours.
- use until diarrhea stops, but not more than 2 days
- children under 12 years: ask a doctor
- Other information
- each tablet contains: calcium 40 mg, salicylate 102 mg
- TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF CELLOPHANE UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
- see end flap for expiration date and lot number
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid excessive heat
- store in a dry place
- Inactive ingredients
calcium carbonate, cherry flavor, D&C red #27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, mannitol, povidone, saccharin sodium, stearic acid, talcClose
- Questions or comments?
- Principal Display Panel
exchange √ select™
The Active Ingredient
Bismuth subsalicylate 262 mg
Upset Stomach Reliever
• Nausea • Upset Stomach
• Heartburn • Diarrhea
30 Cherry Flavored
√ quality value
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF CELLOPHANE UNIT IS TORN,
BROKEN OR SHOWS ANY SIGNS OF TAMPERING
†This product is not manufactured or distributed by
Procter & Gamble, owner of the registered trademark
"SATISFACTION GUARANTEED OR YOUR MONEY BACK"
Manufactured For Your Military Exchanges
Distributed by: LNK International, Inc.,
Hauppauge, NY 11788
Exchange Select 44-319Close
- INGREDIENTS AND APPEARANCE
bismuth subsalicylate tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-319 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 30 (UNII: 2S42T2808B) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) SACCHARIN SODIUM (UNII: SB8ZUX40TY) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) FD&C RED NO. 40 (UNII: WZB9127XOA) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) Product Characteristics Color PINK Score no score Shape ROUND Size 16mm Flavor CHERRY Imprint Code 44;319 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55301-319-01 5 in 1 CARTON 07/16/1998 1 6 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part335 07/16/1998 Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(55301-319) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(55301-319)