Headache Relief To Go
FDA Label NDC 51596-011

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 Headache Relief To Go (NDC 51596-011). 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, liver warning, do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, 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 BOX OR PACKET
IS DAMAGED OR OPEN

Distributed by UrgentRx®
Breakthrough Products, Inc.
Denver, CO 80202

Otc - Purpose

Active ingredients (per powder)Purpose
Acetaminophen 650 mgPain reliever
Caffeine 50 mgPain reliever aid

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 powders in 24 hours. The maximum daily dose for adults is 4000mg in 24 hours.
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Do Not Use

  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Otc - Ask Doctor

Ask a doctor before use if you have liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Otc - When Using

When using this product limit the use of caffeine containing drugs, foods, or drinks, because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat.

Stop Use And Ask A Doctor If

  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present

    • These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see overdose warning)

    • adults and children 12 years and over:

    • place 1 powder on the tongue and swallow with or without water
    • repeat every 4-6 hours, wile symptoms persist
    • do not take more than 6 pouches in 24 hours

      • children under 12 years: ask a doctor

Inactive Ingredients

acesulfame potassium, citric acid, ethylcellulose, flavor, sodium chloride, sucralose, sucrose

Questions?

1-888-99-URGENT (1-888-998-7436) (Mon-Fri 9AM-5PM MDT) or www.urgentRx.com

Principal Display Panel - 10 Packet Box

New
Formula!

Now with
acetaminophen
NO WATER REQUIRED
POUR DIRECTLY IN MOUTH

10 STICK PACKS

HEADACHE

URGENTRX

RELEIF

TO-GO

ACETAMINOPHEN + CAFFEINE/
PAIN RELIEVER + ADJUVANT

sweet orange

Principal Display Panel (10 Packet Box)

Principal Display Panel (10 Packet Box)

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