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Information about Goody's Cool Orange Headache Powder, including its active ingredients (acetaminophen, aspirin, and caffeine), uses, warnings, and directions. It also includes a list of side effects and contraindications. intended for informational purposes only and does not constitute medical advice.
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GOODYS COOL ORANGE HEADACHE- acetaminophen and as pirin and caffeine powder Medtech Products Inc. 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.
Goodys Cool Orange Headache Powder Drug Facts Active ingredients (in each powder) Purpos es Acetaminophen 325 mg........... Pain reliever Aspirin (NSAID*) 500 mg....... Pain reliever Caffeine 65 mg......................................... Pain reliever aid *nonsteroidal anti-inflammatory drug Us es Temporarily relieves minor aches and pains due to: •headache •backache •toothache •menstrual cramps •muscular aches •colds Warnings Reye’s s yndrome : Children and teenagers who have or are recovering from chicken pox 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 shock asthma (wheezing) Acetaminophen may cause severe skin reactions. Symptoms may include: ▪ skin reddening ▪ blisters ▪ rash. If a skin reaction occurs, stop use and seek medical help right away. Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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 a longer time than directed Caffeine warning: This product contains caffeine. Limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, andoccasionally, rapid heart beat. Do not us e if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. As k a doctor before us e if you have liver disease 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 As k a doctor or pharmacis t before us e if you are taking a prescription drug for diabetes, gout or arthritis the blood thinning drug warfarin Stop us e and as k a doctor if an allergic reaction occurs. Seek medical help right away 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 pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear ringing in the ears or a loss of hearing occurs These could be signs of a serious condition. If pregnant or breas t-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. Overdos e warning : Taking more than the recommended dose can cause serious health problems. In
acetaminophen and aspirin and caffeine powder Product Information
Medtech Products Inc. Prod uct T yp e HUMAN O TC DRUG^ Ite m Cod e (S ource ) NDC:6 30 29 -6 6 3 Route of Ad minis tration O RAL Active Ing redient/Active Moiety Ing redient Name Basis o f Streng th Streng th ACETAMINO PHEN (UNII: 36 2O 9 ITL9 D) (ACETAMINO PHEN - UNII:36 2O 9 ITL9 D) ACETAMINO PHEN 325 mg ASPIRIN (UNII: R16 CO 5Y76 E) (ASPIRIN - UNII:R16 CO 5Y76 E) ASPIRIN 50 0 mg CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E) CAFFEINE 6 5 mg Inactive Ing redients Ing redient Name Streng th SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4) GUAR GUM (UNII: E8 9 I16 37KE) MANNITO L (UNII: 3O WL53L36 A) CELLULO SE, MICRO CRYSTALLINE (UNII: O P1R32D6 1U) SUCRALO SE (UNII: 9 6 K6 UQ 3ZD4) Product Characteristics Color S core S hap e S iz e Flavor O RANGE^ **Imp rint Cod e Contains Packag ing
1** NDC:6 30 29 -6 6 3-0 1 24 in 1 BO X; Type 0 : No t a Co mbina tio n Pro duc t 0 6 /0 1/20 12 2 NDC:6 30 29 -6 6 3-0 4 4 in 1 BO X; Type 0 : No t a Co mbina tio n Pro duc t 0 6 /0 1/20 12
Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date O TC MO NO GRAPH NO T FINAL pa rt343 0 6 /0 1/20 12
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