Other
Drug Facts
| Do not use if pouch is torn or open |
distributed by
URGENT Rx®
Breakthrough Products, Inc.
Denver, CO 80202
The following Structured Product Label (SPL) was submitted to the FDA by Breakthrough Products Inc. for the product Headache Relief To Go (NDC 51596-007). 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, otc - purpose, uses, reye's syndrome, allergy alert, stomach bleeding warning, otc - do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
| Do not use if pouch is torn or open |
distributed by
URGENT Rx®
Breakthrough Products, Inc.
Denver, CO 80202
| Active Ingredients (per powder) | Purpose |
|---|---|
| Aspirin 325 mg (NSAID) nonsteroidal anti-inflammatory drug | Pain reliever |
| Caffeine 30 mg | Pain reliever aid |
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.
Aspirin may cause a severe allergic reaction which may include:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
Do not use if you are allergic to aspirin or any other pain reliever/fever reducer
Ask a doctor or pharmacist before use if you are taking a prescription drug for
When using this product limit use of caffeine containing drugs, foods, or drinks, because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat
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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
adults and children 12 years and over
acesulfame potassium, citric acid, flavor, glucose, sucralose
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