Walgreens 44-544546-08RR-delisted
Wal-Phed PE Pressure plus Pain plus Cold by
Drug Labeling and Warnings
Wal-Phed PE Pressure plus Pain plus Cold by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, LNK International, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
WAL-PHED PE PRESSURE PLUS PAIN PLUS COLD DAYTIME, NIGHTTIME, MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl
Walgreen Company
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
Walgreens 44-544546-08RR-delisted
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Phenylephrine HCl 5 mg
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. 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
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.
- 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)
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
- persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache
These could be signs of a serious condition.
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. 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 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 10 caplets in 24 hours
- children under 12 years: ask a doctor
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
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. 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
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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- heart disease
- liver disease
- high blood pressure
- diabetes
- thyroid disease
- glaucoma
- 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, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- new symptoms occur
- 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 swelling is present
These could be signs of a serious condition.
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. 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 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 10 caplets in 24 hours
- children under 12 years: do not use
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
Principal Display Panel
COMBO PACK
Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ
NDC: 0363-9120-08
DAYTIME
MULTI-SYMPTOM
NON-DROWSY
Wal-Phed® PE
PE Pressure + Pain + Cold
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
12
CAPLETS
Actual size
NIGHTTIME MULTI-SYMPTOM
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
12
CAPLETS
Actual size
Compare to SUDAFED PE® PRESSURE + PAIN + COLD Day & Nighttime Cold active ingredients ǂǂ
24 TOTAL CAPLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
ǂWalgreens Pharmacist Survey Study, November 2014.
ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark SUDAFED PE® PRESSURE + PAIN + COLD Day & Nighttime Cold.
50844 REV0614.544/0314.546A08
Walgreens 44-544546-08RR
| WAL-PHED PE PRESSURE PLUS PAIN PLUS COLD
DAYTIME, NIGHTTIME, MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| Labeler - Walgreen Company (008965063) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(0363-9120) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | PACK(0363-9120) | |