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FDA LABEL GENERIC: Acetaminophen MFR: Shield Pharmaceuticals Corp

Apap 325 Mg / Diphenhydramine Hydrochloride 12.5 Mg / Phenylephrine Hydrochloride 5 Mg Oral Tablet

Drug Facts

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Pain reliever

Antihistamine

Nasal decongestant

INDICATIONS AND USAGE

temporarily relieves these symptoms of hay fever and the common cold: runny nose sneezing headache minor aches and pains nasal congestion temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes

WARNINGS

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

more than 4,000 mg of acetaminophen in 24 hours 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  hives facial swelling  asthma (wheezing)  shock

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. with any other product containing diphenhydramine, even one used on skin if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients acetaminophen, ask a doctor or pharmacist.
liver disease glaucoma  thyroid disease  heart disease diabetes  high blood pressure  difficulty in urination due to enlargement of the prostate gland  a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery  avoid alcoholic beverages

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

DOSAGE AND ADMINISTRATION

do not use more than directed adults and children 12 years and over: take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone, povidone*, pregelatinized starch, stearic acid powder, talc, titanium dioxide *may contain these ingredients

1-800-373-6981 (toll-free)

Distributed by:

Shield Pharmaceuticals Corp.

Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL

Allergy plus Sinus headache

Acetaminophen

Diphenhydramine HCl

Phenylephrine HCl

Pain reliever / Antihistamine / Nasal decongestant


Relieves:
runny nose • sneezing • headache
• minor aches and pains • hay fever
• nasal congestion • itching of the nose or throat
• itchy, watery eyes

Carton