HANDY SOLUTIONS HEADACHE PAIN RELIEF- acetaminophen, aspirin, caffeine tablet, film coated
Navajo Manufacturing Company 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.
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Handy Solutions® Headache Pain Relief
Active ingredients (in each tablet)
Acetaminophen 250 mg
Aspirin (NSAID*) 250 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Uses
For the temporary relief of minor aches and pains associated with
• headache • muscular aches • minor arthritis pain • back pain • common cold • toothache • menstrual cramps
Temporarily reduces fever.
Warnings
Reye’s syndrome: 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 of Reye’s syndrome, a rare but serious illness.
Allergy alert: Aspirin (NSAID) may cause a severe allergic reaction which may include:
• hives • skin reddening • facial swelling • rash • asthma (wheezing) • shock • blisters
If an allergic 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: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
Do not use
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• for pain for more than 10 days unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor
• if you ever have had an allergic reaction to any other pain relievers/ fever reducers
• right before or after heart surgery
• if you are taking prescription drugs for gout, diabetes, or arthritis
Ask a doctor before use if
• stomach bleeding warning applies to you
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have a history of stomach problems such as heartburn
• you have asthma
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin • under a doctor’s care for any serious condition • taking any other drug
Stop use and ask a doctor if
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
• symptoms do not improve • pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• ringing in the ears or loss of hearing occurs
• redness or swelling is present in the painful area • any new symptoms appear
Directions
• do not use more than directed
Adults and children (12 years and older): Take 2 tablets with water every 6 hours as needed. Do not take more than 8 tablets in 24 hours.
Children under 12 years: Do not give to children under 12 years of age.
Other Information
• read all product information before using
• store at room temperature 59°-86°F (15°-30°C)
• avoid excessive heat and humidity • tamper evident sealed packets
• do not use any opened or torn packets
| HANDY SOLUTIONS HEADACHE PAIN RELIEF
acetaminophen, aspirin, caffeine tablet, film coated |
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| Labeler - Navajo Manufacturing Company Inc. (091917799) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Navajo Manufacturing Company Inc. | 136941411 | relabel(67751-175) | |