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FDA LABEL GENERIC: Acetaminophen MFR: CHAIN DRUG MARKETING ASSOCIATION, INC.

Apap 325 Mg / Gg 200 Mg / Phenylephrine Hydrochloride 5 Mg Oral Tablet

Drug Facts

Active ingredients (in each caplet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant

Uses

for the temporary relief of the following cold symptoms: minor aches and pains headache sore throat nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

If sore throat is severe, perists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 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

Ask a doctor before use if you have

liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts

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.

Directions

do not take more than directed (see overdose warning)
adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours
children under 12 years ask a doctor

Other information

store between 20-25ºC (68-77ºF) in a dry place retain carton for complete product information and warnings

Inactive ingredients

acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

PRINCIPAL DISPLAY PANEL

QUALITY CHOICE®

NDC 83324-114-24

†Compare to Active Ingredients in TYLENOL® Cold + Head Congestion Severe

For Adults

Cold + Head Congestion Severe

Acetaminophen, Phenylephrine HCl, Guaifenesin

Pain Reliever | Fever Reducer, Nasal Decongestant, Expectorant

For Relief of:

Headache + Body Aches

Fever + Sore Throat

Nasal Congestion Mucus + Chest Congestion

Actual Size

24 COOL TASTE CAPLETS