FDA records indicate that there are no current recalls for this drug.
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Thrulife Extra Strength Headache Relief Recall
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Questions & Answers
Side Effects & Adverse Reactions
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 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
Liver Warning: This product contains acetaminophen.
Severe liver damage may occur if you take · more than 8 tablets 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.
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 heartbeat.
- if you have ever had an allergic reaction to acetaminophen, 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.
- a prescription drug fordiabetes, gout, arthritis
- any other drug containing an NSAID (prescription or nonprescription) · a blood thinning (anticoagulant) or steroid drug ·any other drug, or are under a doctor’s care for any serious condition.
- 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.
- painful area is red or swollen
- any few symptoms appear ·ringing in the ears or loss of hearing occurs.
●pain gets worse or lasts for more than 10 days ● fever gets worse or lasts for more than 3 days
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
temporarily relieves minor headaches and pains due to: ●headache ● muscular aches ● premenstrual & menstrual cramps ● cold● sinusitis ● arthritis ● toothache
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Thrulife Extra Strength Headache Relief Manufacturers
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Polygen Pharmaceuticals Llc
Thrulife Extra Strength Headache Relief | Polygen Pharmaceuticals Llc
do not use more than directed ·drink a full glass of water with each dose ·adults and children 12 years and over: take 2 caplets every 6 hours: not more than 8 caplets in 24 hours · children under 12 years of age: ask a doctor. Adults and children 12 years and over: Take 2 caplets every 6 hours; not more than 8 caplets in 24 hours. Children under 12 years: ask a doctor
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