Multi-Symptom Cold and Cough Daytime Nighttime

WALGREEN CO.

Walgreens 44-544546

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purpose
• Multi-Symptom Cold and Cough Daytime Nighttime Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Multi-Symptom Cold and Cough Daytime Nighttime Other information
• Inactive ingredients
• Active ingredients (in each caplet)
• Purpose
• Multi-Symptom Cold and Cough Daytime Nighttime Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Multi-Symptom Cold and Cough Daytime Nighttime Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Phenyelphrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant 

Multi-Symptom Cold and Cough Daytime Nighttime Uses

• 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

Warnings

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

• more than 12 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminohen
• 3 or more alcoholic drinks every ay while using this product

Sore throat warning: If sore throat is severe, persists 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. 

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 
• persistant 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 or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swellling 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 (1-800-222-1222) right away.  Quickmedical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take only as recommended (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 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

Multi-Symptom Cold and Cough Daytime Nighttime Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number

Inactive ingredients

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

Active ingredients (in each caplet)

Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Antihistamine
Nasal decongestant 

Multi-Symptom Cold and Cough Daytime Nighttime Uses

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

Warnings

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

• more than 12 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminohen
• 3 or more alcoholic drinks every ay while using this product

Sore throat warning: If sore throat is severe, persists 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.
• 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

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• glaucoma
• thyroid disease
• diabetes
• trouble urinating due to an enlarged 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, expecially 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

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

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 (1-800-222-1222) right away.  Quickmedical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take only as recommended (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 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

Multi-Symptom Cold and Cough Daytime Nighttime Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin 

Questions or comments?

1-800-426-9391

Principal Display Panel

COMBO PACK

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0912-09

MULTI-SYMPTOM
NON-DROWSY • DAYTIME
Wal-Phed® PE
PE Cold & Cough 
Acetaminophen / Pain Reliever / Fever Reducer
Dextromethorphan HBr / Cough Suppressant
Guaifenesin / Expectorant
Phenylephrine HCl / Nasal Decongestant
Relieves: • Sore throat •Head & body aches
• Sinus pressure & congestion • Cough • Chest congestion

10
CAPLETS

MULTI-SYMPTOM • NIGHTTIME
Wal-Phed® PE
PE Cold
Acetaminophen / Pain Reliever / Fever Reducer
Diphenhydramine HCl / Antihistamine
Phenylephrine HCl / Nasal Decongestant
Relieves: • Sore throat •Head & body aches
• Runny nose • Sinus pressure & congestion

10
CAPLETS

Compare to Sudafed PE® Day & Night Cold active ingredient ǂǂ

20 TOTAL CAPLETS

ǂWalgreens Pharmacist Survey Study, November 2010
ǂǂThis product is not manufactured  or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Day & NIght Cold.

50844    REV0413.544/0712.546A09

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