FDA Label for Medique Apap Acetaminophen
View Indications, Usage & Precautions
Medique Apap Acetaminophen 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
Otc - Active Ingredient
Active ingredient (in each tablet)
Acetaminophen 325 mg
Otc - Purpose
Pain reliever/fever reducer
Indications & Usage
Uses
temporarily relieves minor aches and pains due to:
headache
muscular aches
minor arthritis pain
backache
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
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 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
pain gets worse and 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.
Otc - 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
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 using and ask a doctor if
pain gets worse and 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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 4 to 6 hours while symptoms last.
do not take more than 10 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 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 (K-30)*, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide*
May contain*
How Supplied
Pain Reliever/Fever Reducer • Acetaminophen 325 mg in a pouch NDC (51662-1273-2)
* Please review the disclaimer below.
