FDA Label for Headache Relief To Go
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- LIVER WARNING
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 10 PACKET BOX
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 mg | Pain reliever |
Caffeine 50 mg | Pain 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)
- 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
adults and children 12 years and over:
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.