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FDA LABEL GENERIC: Acetaminophen MFR: Focus Consumer Healthcare, LLC

Apap 500 Mg / Pamabrom 25 Mg / Pyrilamine Maleate 15 Mg Oral Tablet [premsyn Pms]

(in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

Pain reliever

Antihistamine

Diuretic

INDICATIONS AND USAGE

For the temporary relief of these symptoms associated with menstrual periods:

cramps
headache
bloating
backache
water-weight gain
muscular aches
irritability

WARNINGS

Allergy Warning: 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.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

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



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.

Ask a doctor before use if you have:

liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargment of the prostate gland.

Ask a doctor or pharmacist before use if you are:

taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product, you may get drowsy, avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving or operating machinery excitability may occur, especially in children

stop use and ask 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 If pregnant or breastfeeding, ask a health professional before 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.

you have

liver disease
glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

if you are

taking the blood thinning drug warfarin 
taking sedatives or tranquilizers
you may get drowsy, avoid alcoholic beverages
alcohol, sedatives and tranquilizers may increase drowsiness
use caution when driving or operating machinery
excitability may occur, especially in children
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

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE AND ADMINISTRATION

adults and children 12 years and over:

take 2 caplets with water every 6 hours as needed
do not exceed 8 caplets in a 24 hour period or as directed by a doctor
do not use more than directed (see warnings)

children under 12 years: ask a doctor

blue 2, candelilla wax, corn starch, ethylparaben, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregalatinized starch, propylaparaben, red 40, sodium starch glycolate, stearic acid, talc, titanium dioxide

ASK A DOCTOR