Allergy and Cold

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-583

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

• temporarily relieves these symptoms of the common cold or hay fever or other upper respiratory allergies:
  • sneezing
  • runny nose
  • itchy, watery eyes
  • headache
  • sore throat
  • nasal congestion
  • cough
  • minor aches and pains
  • itching of the nose or throat
• temporarily reduces fever

Liver warning:

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

more than 12 gelcaps 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:

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.

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• trouble urinating due to an enlarged prostate gland
• cough accompanied by too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• 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
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery

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,

Keep out of reach of children.

• do not use more than directed (see overdose warning)
• adults and children 12 years and over
  • take 2 gelcaps every 4 hours
  • do not take more than 12 gelcaps in 24 hours
• children under 12 years
  • do not use 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 between 20º to 25ºC (68º to 77ºF).  Avoid high humidity.
• see end flap for expiration date and lot number

Principal Display Panel

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

CVS®

pharmacy

*Compare to the active ingredients in Benadryl® Allergy Plus Cold

NEW!

ALLERGY & COLD

WITH FEVER REDUCER

ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl

Pain reliever/Fever reducer, Antihistamine/Cough suppressant,

Nasal decongestant

See New Warnings Information

Relief of:

✓ Headache    

✓ Sneezing

✓ Sore throat & Fever

✓ Itchy, watery eyes

✓ Sinus congestion

✓ Runny nose

✓ Itchy Throat

✓ Cough

24 GELCAPS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING

Distributed by:

CVS Pharmacy, Inc.

One CVS Dive

Woonsocket, RI 02895

© 2010 CVS/pharmacy

www.cvs.com

1-800-shop-CVS

50844   ORG110958308