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Multi Symptom Cold by Honeywell Safety Products USA, Inc

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 162mg, GUAIFENESIN 200mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg
Labeler: Honeywell Safety Products USA, Inc
NDC Code: 0498-1170

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Multi Symptom Cold

Active Ingredients (in each tablet)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose
  • Pain reliever/fever reducer
  • Antitussive
  • Expectorant
  • Nasal decongestant

Uses

temporarily reduces fever and relieves the following cold symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • cough

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

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

  • more than 4,000 mg acetaminophen in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen (prescription or nonprescription).
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If skin reaction occurs, stop use and seek medical help.


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
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate
  • persistant 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 dose

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
  • new symptoms occur
  • redness or swelling i 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; In case of overdose, get medical help or contact a Poison Control Center right away (1-800-922-1222). Prompt 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 of age and older: take 2 tablets every 6 to 8 hours as needed
  • do not exceed 8 tablets in 24 hours, unless directed by a doctor.
  • children under 12 years of age: consult a doctor

Other Information
  • store at controlled room temperature 15 o-30 oC (59 o-86 oF)
  • avoid excessive heat and humidity
  • TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN

Inactive Ingredients

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid

Questions or comments?

1-800-430-5490

MultiSymptom Cold

Multi Symptom Cold

MULTI SYMPTOM COLD 
acetaminophen, dextromethorphan, phenylephrine, guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-1170
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE162 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN 
STEARIC ACID 
POVIDONE K30 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
Colororange (BRIGHT ORANGE) Scoreno score
ShapeROUNDSize12mm
FlavorImprint CodeFR;12
Contains    
Packaging
#Item CodePackage Description
1NDC:0498-1170-50500 PACKET in 1 CARTON
1NDC:0498-1170-012 TABLET in 1 PACKET
2NDC:0498-1170-10100 PACKET in 1 BOX
2NDC:0498-1170-012 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/02/2017
MULTI SYMPTOM COLD 
acetaminophen, dextromethorphan, phenylephrine, guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-1070
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE162 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID 
POVIDONE K30 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MALTODEXTRIN 
Product Characteristics
Colororange (BRIGHT ORANGE) Scoreno score
ShapeROUNDSize12mm
FlavorImprint CodeFR;12
Contains    
Packaging
#Item CodePackage Description
1NDC:0498-1070-50250 CARTON in 1 CARTON
1NDC:0498-1070-25125 CARTON in 1 CARTON
1NDC:0498-1070-1050 PACKET in 1 CARTON
1NDC:0498-1070-012 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/24/201201/01/2017
Labeler - Honeywell Safety Products USA, Inc (079287321)
Registrant - Honeywell Safety Products USA, Inc (079287321)
Establishment
NameAddressID/FEIOperations
Honeywell Safety Products USA, Inc079287321repack(0498-1070, 0498-1170)

 
Honeywell Safety Products USA, Inc

← See all Multi Symptom Cold brands

Medically reviewed on Sep 6, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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