FDA Label for Aerotab Pain Reliever
View Indications, Usage & Precautions
Aerotab Pain Reliever 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.
Active Ingredient
Drug Facts
Active Ingredients (per tablet)
Acetaminophen 500mg
Caffeine 65mg
Purpose
Acetaminophen 500mg.............Pain Reliever / Fever Reducer
Caffeine 65mg...........................Pain Reliever Aid
Uses
Temporarily relieves minor aches and pains due to:
- headaches
- muscular aches
Warnings
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- more than 8 caplets 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
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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 occasionaly, rapid heartbeat.
Otc - Do Not Use
Do not use
- if you are allergic to ascetaminophen
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure wheter 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
- any new symptoms occur
- painful area is red or swollen
- pain gets worse or lasts form ore than 10 days
- fever gets worse or lasts for more than 3 days.
These could be signs of a serious condition.
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 overdose, get medical help or contact a 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
- do not use more than directed
- 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
Other Information
- Store at 20-25 C (68-77 F)
- do not use of pouch is torn or open
Inactive Ingredients
corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide.
Questions Or Comments?
Call 1-845-618-7037
Package Label.Principal Display Panel
AEROTAB
Pain Reliever
fever reducer
Acetaminophen 500mg
Caffeine 65mg
Extra Strength
Relieves aches and pains
Fever reducer
2 per packet
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