Label: HEADACHE RELIEF TO GO- aspirin and caffeine powder
-
Contains inactivated NDC Code(s)
NDC Code(s): 51596-007-01, 51596-007-05, 51596-007-12, 51596-007-24 - Packager: Breakthrough Products Inc.
- Category: HUMAN OTC DRUG LABEL
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 November 5, 2013
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
Warnings
Reye's syndrome
Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert
Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
Stomach bleeding warning
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for longer than directed
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- gout
- diabetes
- arthritis
When using this product limit 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
- an allergic reaction occurs (seek medical help right away)
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- fever lasts more than 3 days
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- Directions
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Pouch Label
-
INGREDIENTS AND APPEARANCE
HEADACHE RELIEF TO GO
aspirin and caffeine powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51596-007 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E) aspirin 325 mg caffeine (UNII: 3G6A5W338E) (caffeine - UNII:3G6A5W338E) caffeine 30 mg Inactive Ingredients Ingredient Name Strength acesulfame potassium (UNII: 23OV73Q5G9) anhydrous citric acid (UNII: XF417D3PSL) dextrose (UNII: IY9XDZ35W2) sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color WHITE Score Shape Size Flavor LEMON (Lemon-Lime) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51596-007-05 5 in 1 BOX 1 NDC:51596-007-01 1 in 1 POUCH 2 NDC:51596-007-12 12 in 1 BOX 2 NDC:51596-007-01 1 in 1 POUCH 3 NDC:51596-007-24 24 in 1 BOX 3 NDC:51596-007-01 1 in 1 POUCH 4 NDC:51596-007-01 1 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 10/01/2012 Labeler - Breakthrough Products Inc. (962008251)
