Home – Non Drowsy Cold and Cough PE

Non Drowsy Cold and Cough PE

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-546

FULL PRESCRIBING INFORMATION: CONTENTS*

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FULL PRESCRIBING INFORMATION

Acetaminophen 325 mg

Dextromathorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

temporarily relieves these symptoms due to the common cold:
- nasal congestion
- headache
- minor aches and pains
- cough
- sore throat
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
temporarily reduces fever

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

more than 12 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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompained 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 shopping the 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 are

taking 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, cough, or nasal congestion 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: Taking more than the recommended dose (overdose) may cause liver damage. 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.

do not use more than directed (see overdose warning)
adults and children 12 years and over
- take 2 caplets every 4 hours
- do not take more than 12 caplets in 24 hours
children under 12 years: do not uses this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

store at controlled room temperature 15º-30ºC (59º-86ºF)
see end flap for expiration date or lot number

corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maletodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gle, sodium starch glycolate, stearic acid, talc, titanium dioxide

1-800-426-9391

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The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

CVS®

pharmacy

NDC 59779-546-03

Compare to the active ingredients in Sudafed PE® Cold & Cough*

NON-DROWSY

COUGH & COLD PE

MULTI-SYMPTOM

ACETAMINOPHEN, DEXTROMATHORPHAN HBr

GUAIFENESIN, PHENYLEPHRINE HCl

PAIN RELIEVER/FEVER REDUCER, EXPECTORANT

COUGH SUPPRESSANT, NASAL DECONGESTANT

•Nasal & sinus congestion

•Chest congestion

•Fever & body aches

•Cough & sore throat

Does not contain Pseudoephedrine

* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed ® PE Cold & Cough.

50844 REV0510B54603

Distributed by: CVS Pharmacy, Inc.

One CVS Ddrive, Woonsocket, RI 02895