Desempacho by Pharmalab Enterprises Inc. Drug Facts

Desempacho by

Drug Labeling and Warnings

Desempacho by is a Otc medication manufactured, distributed, or labeled by Pharmalab Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESEMPACHO CUCHARADAS- bismuth subsalicylate liquid 
Pharmalab Enterprises Inc.

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.

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Drug Facts

Active Ingredient (in each 15 mL tablespoon)                             Purpose

Bismuth Subsalycilate 262 mg  ......................................................... upset stomach reliever

                                                                                                           and antidiarrheal

Uses

Uses 

Relieves:

• Heartburn
• Indigestion
• Upset Stomach
• Nausea
• Diarrhea

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 or 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 salicilates (including aspirin)
Taking other salicylate products

Do not use if you have:

• An ulcer
• A bleeding problem
• Bloody or black stool

Ask a doctor before use if you have

• Fever
• Mucus in the stool

Ask a doctor or pharmacist before use if you are taking any drug for:

• Anticoagulation (thinning the blood)
• Diabetes
• Gout
• Arthritis

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

Stop use and ask a doctor if:

• Symptoms get worse
• Ringing in the ears or loss of hearing occurs
• Diarrhea lasts more than 2 days

If pregnant or breast-feeding,ask a health professional before use

Keep out of the reach of children.

Directions:

Shake well before use

Adult and children 12 years and over: 1 dose (2tbsp or 30 mL) every 1/2 hour as needed, do not exceed 8 doses (16 Tbsp or 240 mL) in 24 hours.



Use until diarrhea stops, but not more than 2 days.


Children under 12 years: ask a doctor

Drink plenty of water or clear fluids to help prevent dehydration caused by diarrhea.

Modo de uso

Agitese antes de usarse

Adultos y ninos mayores de 12 anos:

Una dosis (2 cucharadas o 30 mL) cada 1/2 hora segun necesidad, no exceder de 8 dosis (16 cucharadas 240 mL) en 24 horas.

Use mientras tenga diarrea, pero no por mas de 2 dias.

Ninos menores de 12 anos, consultar al doctor.

Tomar bastante agua o fluidos para prevenir deshidratacion cuasada por la diarrea.

Other Information

Each tablespoon contains: Sodium 6 mg, Low sodium, Sugar free, Salicylate 130 mg. Protect from freezing. Avoid excessive heat (more than 140 F or 40 C)

Tamper-Evident: Do not use if imprinted shrinkband is missing or broken

Distributed by: Perez Distributing Fresno

Sanger, California 93657

www.perezdistfresno.com

email: ordenes@perezdistfresno.com

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

DESEMPACHO  CUCHARADAS
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14505-400
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	pink (Pink)	Score
Shape		Size
Flavor	CHERRY (Cherry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14505-400-08	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/09/2009	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	01/09/2009	01/01/2020

Labeler - Pharmalab Enterprises Inc. (174401088)

Revised: 4/2020

Document Id: c77ea14f-c5b6-4ec9-8fe7-618e08a022c8

34390-5

Set id: 156425c0-2269-4feb-a9f6-de70dd00eb36

Version: 6

Effective Time: 20200418