PE multi-stymptom cold and cough relief description, usages, side effects, indications, overdosage, supplying and lots more!

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PE multi-stymptom cold and cough relief

Target Corporation

Target 44-546


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Acetaminophen 325 mg
Dextromathorphan HBr 10 mg
Guaifenesin 100 mg
Phenylephrine HCl 5 mg

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

  •  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

 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.

  • 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
  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date or lot number

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

1-800-426-9391

Principal Display Panel

NDC 11673-546-09

PE multi-symptom cold and cough relief
non-drowsy
acetaminophen, dextromethorphan HBr
guafenesin, phenylephrine HCl

Compare to active ingredient in Sudafed PE ® Cold & Cough*

relieves cough and sore throat/fever/minor aches and pains/chest congestion/nasal and sinus congestion

up & up®

20 COATED CAPLETS SHOWN ACTUAL SIZE ABOVE

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Cold & Cough..
50844    ORG081036910

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

PE multi-stymptom cold and cough relief
Target 44-546

PE multi-stymptom cold and cough relief

Acetaminophen, Dextromathorphan HBr, Gauifenesin, Phenylephrine HCl CAPSULE, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11673-645
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Guaifenesin GUAIFENESIN 100 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIED
CROSPOVIDONE
MAGNESIUM STEARATE
maltodextrin
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
POVIDONES
DIATOMACEOUS EARTH
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
ORANGE 17 mm 44;546 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20 in 1 BLISTER PACK
2 NDC:11673-645-09 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-02-22


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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