FDA Label for Aerotab Non-aspirin
View Indications, Usage & Precautions
Aerotab Non-aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Aero Healthcare. 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
Acteminophen 500 mg
Otc - Purpose
Pain reliever / fever reducer
Uses
temporary relief of minor aches and pains associated with
- common cold
- headache
- toothache
- muscular aches
- backache
- arthritis
- menstrual cramps
- temporarily reduces fever
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4000 mg of acetaminophen in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy Warning: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Otc - Do Not Use
Do not use
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription).
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Otc - Ask Doctor
Ask a doctor before use if you have liver disease.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
Otc - Stop Use
Stop use and ask a doctor if
- symptoms do not improve
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- redness or swelling is present
- a rare sensitivity reaction occurs
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- take only as directed - see Overdose warning
- do not take more than 8 tablets in any 24 hour period
- do not use more than 10 days unless directed to do so by a doctor
Adults and children 12 years and over: take 2 tablets every 4 to 6 hours.
Children under 12 years of age: do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
Other Information
Tamper evident. Do not use if packet is torn, cut or opened. Store between 20°-25°C (68°-77°F). Read all warnings and directions before use.
Inactive Ingredients
corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Package Label.Principal Display Panel
AEROTAB
Non-Aspirin
acetaminophen 500mg
Fever reducer
Pain Reliever
Relieves aches
2 per packet
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