FDA Label for Headache Relief To Go

View Indications, Usage & Precautions

Headache Relief To Go Product Label

The following document was submitted to the FDA by the labeler of this product Breakthrough Products Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.