Meijer 44-511-Discontinued
Cough and Sinus PE Pressure, Pain and Cough by
Drug Labeling and Warnings
Cough and Sinus PE Pressure, Pain and Cough by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution Inc, LNK International, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
COUGH AND SINUS PE PRESSURE, PAIN AND COUGH NON-DROWSY- acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Meijer Distribution Inc
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.
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Meijer 44-511-Discontinued
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- nasal congestion
- cough
- sore throat
- sinus congestion and pressure
- temporarily reduces fever
- promotes nasal and sinus drainage
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) 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, 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, 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
- diabetes
- heart disease
- thyroid disease
- high blood pressure
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
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
- new symptoms occur
- redness or swelling is present
- fever gets worse or lasts more than 3 days
- 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.
Directions
-
do not take more than directed
- 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
- 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, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, talc, titanium dioxide
Principal display panel
NDC: 41250-511-08 Compare to SUDAFED PE® PRESSURE + PAIN + COUGH active ingredients*
meijer®
Non - Drowsy
Cough & Sinus PE
Pressure, Pain & Cough
Acetaminophen Pain reliever/Fever reducer
Dextromethorphan HBr Cough suppressant
Phenylephrine HCl Nasal decongestant
Relieves:
Fever, Headache, Sore Throat,
Nasal Congestion & Cough
For Adults
24 CAPLETS Actual Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark SUDAFED PE® PRESSURE + PAIN + COUGH.
50844 REV0915A51108
DIST. BY MEIJER Meijer 44-511
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com
| COUGH AND SINUS PE PRESSURE, PAIN AND COUGH
NON-DROWSY
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated |
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| Labeler - Meijer Distribution Inc (006959555) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(41250-511) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | PACK(41250-511) | |