HEADACHE RELIEF TO GO- acetaminophen and caffeine powder

Headache Relief To Go by

Drug Labeling and Warnings

Headache Relief To Go by is a Otc medication manufactured, distributed, or labeled by Breakthrough Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

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

Warnings

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.

Ask a doctor before use if you have liver disease

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

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.

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

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

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DO NOT USE IF BOX OR PACKET
IS DAMAGED OR OPEN

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

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

INGREDIENTS AND APPEARANCE

HEADACHE RELIEF TO GO 
acetaminophen and caffeine powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51596-011
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D)	acetaminophen	650 mg
caffeine (UNII: 3G6A5W338E) (caffeine - UNII:3G6A5W338E)	caffeine	50 mg

Inactive Ingredients
Ingredient Name	Strength
acesulfame potassium (UNII: 23OV73Q5G9)
citric acid monohydrate (UNII: 2968PHW8QP)
ethylcelluloses (UNII: 7Z8S9VYZ4B)
sodium chloride (UNII: 451W47IQ8X)
sucralose (UNII: 96K6UQ3ZD4)
sucrose (UNII: C151H8M554)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51596-011-10	10 in 1 BOX
1	NDC: 51596-011-01	1 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	07/15/2014

Labeler - Breakthrough Products Inc. (962008251)