Label: HEADACHE RELIEF TO GO- acetaminophen and caffeine powder
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Contains inactivated NDC Code(s)
NDC Code(s): 51596-010-01 - Packager: Breakthrough Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 16, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 powders in 24 hours which is the maximum daily amount
- 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.
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.
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Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over
- see instructions above for opening packet
- 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
- Questions?
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL - Pouch Label
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INGREDIENTS AND APPEARANCE
HEADACHE RELIEF TO GO
acetaminophen and caffeine powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51596-010 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:51596-010-01 1 in 1 POUCH 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)
