Critical Care Aspirin To Go
FDA Label NDC 51596-006

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Breakthrough Products Inc. for the product Critical Care Aspirin To Go (NDC 51596-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (per powder), purpose, uses, reye's syndrome, allergy alert, stomach bleeding warning, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Do not use if pouch
is torn or open

distributed by
URGENT Rx®
Breakthrough Products, Inc.
Denver, CO 80202

Active Ingredient (Per Powder)

Aspirin 325mg (NSAID)

nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

Temporarily relieves:

  • headache
  • toothache
  • pain of colds
  • muscle pain
  • menstrual pain
  • minor pain of arthritis

Reye's Syndrome

Children and teenagers who have or are recovering from chickenpox 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

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach Bleeding Warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for longer than directed

Otc - Do Not Use

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer.

Ask A Doctor Before Use If

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

Otc - Ask Doctor/Pharmacist

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

  • gout
  • diabetes
  • arthritis

Stop Use And Ask A Doctor If

  • an allergic reaction occurs (seek medical help right away)
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever lasts more than 3 days
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Otc - 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.

Directions

adults and children 12 years and over:

  • see instructions in red box for opening packet
  • place 1-2 powders on the tongue and swallow with or without water
  • repeat every 4-6 hours, while symptoms persist
  • do not take more than 8 powders in 24 hours

    • children under 12 years: ask a doctor

Inactive Ingredients

acesulfame potassium, citric acid, flavor, glucose, sucralose

Questions?

1-888-998-7436 (Mon-Fri 9AM-5PM MDT)

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NO
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REQUIRED
POUR DIRECTLY IN MOUTH

SEE OPENING INSTRUCTIONS ON BACK PANEL

CRITICAL
CARE
325
mg

URGENT Rx®

ASPIRIN
TO-GO™

ASPIRIN (NSAID) /
PAIN RELIEVER

lemon-lime

distributed by UrgentRx
1 POWDER PACK

Principal Display Panel (325 mg Pouch Label)

Principal Display Panel (325 mg Pouch Label)

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