FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Warnings: For external use only.
Do not use: with electrocautery, in the eyes.
Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.
Warnings:
For external use only.
Do not use: in eyes; over large areas of the body;
If allergic to any of the ingredients; for more than one week unless directed by a physician.
Stop use and consult a doctor:
if the condition persists or gets worse; a rash or other allergic reaction develops
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomachbleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing 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
Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer, right before or after heart surgery.
Ask a doctor before use if stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic
Ask a doctor before use if you are:
taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; 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 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 in the painful area; any new symptoms appear
Warnings
Liver Warning: This product contains acetaminophen. Sever 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.
Do not use: with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist.
for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop using and ask a doctor if
symptoms do not improve
new symptoms occur
pain or fever persists or gets worse
redness or swellign is present
Warning: For external use only.
Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.
Do not use in the eyes or over large areas of the body.
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
Uses for the temporary relief of minor aches and pains associated with
headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever
History
There is currently no drug history available for this drug.
Other Information
LOT/EXP: Made in CHINA
20140301
Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755
LOT/EXP: Made in CHINA
20130301
Sources
Genuine First Aid – Auto First Aid Manufacturers
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Genuine First Aid, Llc
Genuine First Aid – Auto First Aid | Genuine First Aid, Llc
Directions:
do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor.
Adults and Children (12 years and older): Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.
Children under 12 years: Do not give to children under 12 years of age.Adults and children: (12 years and older)
take 2 tablets every 4 to 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.
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