FDA Label for Pain Reliever
View Indications, Usage & Precautions
Pain Reliever Product Label
The following document was submitted to the FDA by the labeler of this product Advanced First Aid, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
ACTIVE INGREDIENT IN EACH TABLET- ACETAMINOPHEN 110 MG, ASPIRIN 162 MG, CAFFEINE 32.4 MG, SALICYLAMIDE 152 MG
Otc - Purpose
PAIN RELIEVER/FEVER REDUCER
Indications & Usage
Uses:
temporarily relieves minor aches and pains associated with:
• headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • backache
Warnings
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 behaviour 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.
Alergy Alert: 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.
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 with 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 product containing acetaminophen (prescription or nonprescription). This will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.
• with any other pain reliever/fever reducer
• if you are allergic to aspirin
• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor
Ask doctor before using if you have:
• stomach problems (such as heartburn, upset stomach or stomach pain)
• stomach bleeding warning applies to you
• gastric ulcers • bleeding problems
• you have asthma, high blood pressure, heart disease, liver disease, or kidney disease
• you are taking a diuretic
Ask a doctor or pharmacist before use if you are taking a prescription drug for:
•anticoagulation (thinning of blood) • diabetes • gout • arthritis
• und a doctor's care for any serious condition
• taking any other drug
When using this product do not exceed recommended dose.
Stop use and ask a doctor if:
• ringing in the ears or loss of hearing occurs
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present
• you feel faint, vomit blood or have bloody or black stools, have stomach pain that does not get better. These are signs of stomach bleeding.
• an allergic reaction occurs.
Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding baby, ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN
DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT
MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.
Otc - Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for
adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Adults and children 12 years of age and older:Take 2 tablets every 4 hours as
needed, with a full glass of water. Do not exceed 8 tablets in any 24 hour period.
Children under 12 years: ask a doctor.
Inactive Ingredient
FD&C yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch and stearic acid
Package Label.Principal Display Panel
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