Severe Cold and Flu description, usages, side effects, indications, overdosage, supplying and lots more!

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Severe Cold and Flu

WALGREEN CO.

Walgreens 44-640


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal Congestant

Severe Cold and Flu Uses

  • temporarily relieves common cold and flu symptoms:
    • minor aches and pains
    • sinus congestion and pressure
    • sore throat
    • fever
    • headache
    • nasal congestion
    • cough due to minor throat and bronchial irritation
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive 

Warnings

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

  • more than 8 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 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 usre 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
  • thyroid disease
  • diabetes
  • heart disease
  • high blood pressure
  • 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, nasal congestion, or cough 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 be fever, rash, or persistent headache

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. 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 take more than directed
    (see overdose warning)
  • do not take more than 8 caplets in 24 hours
  • adults and children 12 years and older: take 2 caplets every 4 hours
  • children 4 to under 12 years of age: ask a doctor
  • children under 4 years of age: do not use

Severe Cold and Flu Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER UNIT 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, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0640-08

DAYTIME
MAXIMUM STRENGTH
NON-DROWSY
SEVERE
Cold & Flu
Acetaminophen
325 mg / Pain Reliever / Fever Reducer
Dextromethorphan HBr 10 mg / Cough Suppressant
Guaifenesin 200 mg / Expectorant
Phenylephrine HCl 5 mg / Nasal Decongestant
• Relieves headache, fever, sore throat, minor aches & pains, cough, chest congestion, nasal/sinus congestion & sinus pressure
24
CAPLETS

DAYTIME

Compare to Vicks® DayQuil® Severe Cold & Flu active ingredientsǂǂ

ǂWalgreens Pharmacist Survey Study, November 2012
ǂǂThis product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® Severe Cold & Flu.
50844    ORG101364008

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

Severe Cold and Flu
Walgreens 44-640

Severe Cold and Flu

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0363-0640
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 200 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
CROSPOVIDONE
FD&C RED NO. 40
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
maltodextrin
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
polysorbate 80
POLYVINYL ALCOHOL
POVIDONES
SILICON DIOXIDE
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
ORANGE 19 mm 44;640 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:0363-0640-08 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-10-31


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