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

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Daytime Multi-Symptom Severe Cold

WALGREEN CO.

Walgreens 44-503C


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

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

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Daytime Multi-Symptom Severe Cold Uses

  • temporarily relieves these common cold/flu symptoms
    • minor aches and pains
    • headache
    • nasal congestion
    • sore throat
    • impulse to cough 
    • cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe 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 accompanied for 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

  • liver disease
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • 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

  •  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
  • 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.

Directions

  • do not take more than directed (see overdose warning)
  • 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 12 caplets 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 

Daytime Multi-Symptom Severe Cold Other information

  • 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, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Principal Display Panel

Well at
Walgreens
WALGREEN PHARMACIST RECOMMENDEDǂ

NDC 0363-0503-08

MULTI-SYMPTOM
NON-DROWSY
DAYTIME
Severe
Cold
Acetaminophen
/
Fever / Headache / Sore Throat
Phenylephrine HCl / Nasal Congestion
Dextromethorphan HBr / Coughing
Guaifenesin / Chest Congestion
• Pain reliever, fever reducer, nasal decongestant, cough suppressant & expectorant

24
CAPLETS

Compare to Tylenol® Cold Multi-Symptom Severe Daytime Caplets active ingredientsǂǂ

PSEUDOEPHEDRINE FREE • COOL BLAST FLAVOR

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

ǂWalgreens Pharmacist Survey Study, November 2010.
ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Multi-Symptom Severe Daytime.        50844    ORG011150308

Daytime Multi-Symptom Severe Cold
Walgreen 44-503

Daytime Multi-Symptom Severe Cold

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0363-0503
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
CROSPOVIDONE
D&C YELLOW NO. 10
MAGNESIUM STEARATE
maltodextrin
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
POVIDONES
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
YELLOW 19 mm 44;503 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:0363-0503-08 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-08-04


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