FDA Label for Medique Apap Extra Strength Acetaminophen Tablet, Film Coated
View Indications, Usage & Precautions
Medique Apap Extra Strength Acetaminophen Tablet, Film Coated Product Label
The following document was submitted to the FDA by the labeler of this product Hf Acquisition Co Llc, Dba Healthfirst. 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.
Other
Drug Facts
Active Ingredient
Active ingredient (in each tablet)
Acetaminophen 500 mg
Purpose
Purpose
Pain reliever/fever reducer
Indications & Usage
Uses
temporarily relieves minor aches and pains due to:
headache
muscular aches
minor pain of arthritis
backahe
the common cold
toothache
premenstrual and menstrual cramps
temporarily reduces fever
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
more than 4,000 mg 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
Allergy 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.
Do Not Use
Do not use
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug
contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask Doctor
Ask a doctor before use if you have
liver disease
Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if
you are taking the blood thinning drug warfarin
Stop Use
Stop use and ask a doctor if
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
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning:
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
do not use more than directed (see overdose warning)
Adults and children: (12 years and over)
take 2 tablets every 6 hours while symptoms last.
do not take more than 6 tablets in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor
Children under 12 years: Ask a doctor
Other Safety Information
Other information
store at room temperature 59°-86°F (15°-30°C)
tamper-evident sealed packets
do not use any opened or torn packets
Inactive Ingredient
Inactive ingredients
corn starch, hypromellose*, polyethylene glycol*, povidone, pregelatinized corn starch*, sodium starch glycolate*, stearic acid*, titanium dioxide*
*may contain
Questions
Questions or comments? 1-800-634-7680
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
* Please review the disclaimer below.