Multi-Symptom Nighttime Cold description, usages, side effects, indications, overdosage, supplying and lots more!

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Multi-Symptom Nighttime Cold

WALGREEN CO.

Walgreens 44-591


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg 

Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant 

  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • nasal congestion
    • cough
    • sore throat
    • sinus congestion and pressure
    • sneezing and runny rose
  • helps clear nasal passages
  • relieves cough to help you sleep
  • temporarily reduces fever

Warnings

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

  • more than 12 gelcaps 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 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. 

Ask a doctor before use if you have

  • liver disease
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • persistent or chronic cough such as occurs with smoking, asthma, 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
  • taking sedatives or tranquilizers 

When using this product

  • do not exceed recommended dosage
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
  • avoid alcoholic drinks 

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
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • 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 take more than directed
    (see overdose warning)
  • adults and children 12 years and over
    • take 2 gelcaps every 4 hours
    • do not take more than 12 gelcaps in 24 hours
  • children under 12 years: do not use 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 25ºC (77ºF); excursions permitted between 15º-30º C (59º-86ºF)
  • see end flap for expiration date and lot number

ammonium hydroxide, black iron oxide, croscarmellose sodium, crospovidone, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, red iron oxide, shellac glaze, silica gel, simethicone, stearic acid, titanium dioxide, yellow iron oxide 

1-800-426-9391

Principal Display Panel

NDC 0363-0591-08

Well at Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NIGHTTIME
MULTI-SYMPTOM
Cold
Acetaminophen /
Fever / Headache / Sore Throat
Chlorpheniramine maleate / Runny Nose
Dextromethorphan HBr / Coughing
Phenylephrine HCl / Nasal Congestion
• Pain reliever, fever reducer, antihistamine
• Fast-release Quick Gels™

36 GELCAPS

Compare to Tylenol® Cold Multi-Symptom NIghttime active ingredientsǂǂ

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

DOES NOT CONTAINS GLUTEN
50844    REV0712B59108

ǂWalgreen Pharmacist Survey Study, November 2012.
ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Mult-Symptom Nighttime. 

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
www.walgreens.com        ©2013 Walgreen Co.

Multi-Symptom Nighttime Cold
Walgreens 44-591

Multi-Symptom Nighttime Cold

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, GELATIN COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0363-0591
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
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POVIDONES
propylene glycol
SILICON DIOXIDE
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BLUE (divided by gray band) 19 mm 44;591 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:0363-0591-08 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2008-03-29


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Be sure to consult your doctor before taking any medication!
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