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Non Drowsy Cold and Cough PE (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg guaifenesin 100 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. SUPERVALU INC.

Generic: acetaminophen, dextromathorphan hbr, gauifenesin, phenylephrine hcl

Non Drowsy Cold and Cough PE capsule, coated - (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg guaifenesin 100 mg phenylephrine hydrochloride 5 mg) image

IMPRINT: 44 546     SHAPE: capsule
    COLOR: orange

  1. FDA Adverse Reactions

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Active Ingredients (in Each Caplet)


Acetaminophen 325 mgDextromathorphan HBr 10 mgGuaifenesin 100 mgPhenylephrine HCl 5 mg

Purpose


Pain reliever/fever reducerCough suppressantExpectorantNasal decongestant

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.  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.

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 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

Other Information

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

Inactive Ingredients


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

Questions Or Comments?


 1-877-932-7948

Principal Display Panel


equaline®

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

NDC 41163-546-09

non-drowsy cough & cold PE multi-symptom acetaminophen, dextromathorphan HBr, guaifenesin, phenylephrine HClpain reliever/fever reducer,nasal decongestant, expectorant, cough suppressant

• fever & minor aches & pains • nasal & sinus congestion • chest congestion • cough & sore throat

pseudoephedrine free

20 caplets 10 doses, 2 pill/dose

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Cold & Cough.50844        REV0712B54609

DISTRIBUTED BY SUPERVALU INC. EDEN PRARIE, MN 55344 USA

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Equaline 44-546

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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