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Multi Symptom Cold by North Safety Products LLC

Medically reviewed on December 14, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 162mg, GUAIFENESIN 200mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg
Labeler: North Safety Products LLC
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
Guaifenesein 200 mg
Phenylephrine HCl 5 mg
Dextromethorphan HBr. 15 mg

Purpose

Pain reliever/fever Reducer, expectorant, decongestant, antitussive

Uses

temporarily:

• relieves nasal congestion associated with sinusitis

• relieves nasal congestion due to the common cold, hay fever or other

upper respiratory allergies

• relieves sinus congestion and pressure ,helps decongest sinus openings and passages

• restores free breathing

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus,drain bronchial tubes, and make coughs more productive.

• temporarily suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

temporarily relieves minor aches, pains, and fever associated with:

• headache

• common cold

• toothache

• backache

• muscular aches

• menstrual cramps

Warnings

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

• more than 8 tablets 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.


Do not:

• use with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.

• use more than the recommended dose

• for more than 10 days for pain unless directed by a doctor

• for more than 3 days for fever unless directed by a doctor

• when using this product do not exceed recommended dose.

• 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 MAOI drug. If you do not know if your prescription

drug contains an MAOI, consult a doctor or pharmacist before

taking this product

Stop use and ask a doctor if:

• symptoms do not improve

• pain or fever persists or gets worse

• new symptoms occur

• redness or swelling is present

• nervousness, dizziness or sleeplessness occur

• symptoms do not improve within 7 days or are accompanied by

fever

• cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition

Ask a doctor before use if you have:

  • liver disease


• heart disease


• high blood pressure

• thyroid disease

• diabetes

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

• difficulty in urination due to enlargement of the prostate gland

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

If pregnant or breast-feeding, ask a health professional

before use.

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions


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, or as directed by a doctor.

• Children under 12 years, consult a doctor

Other Information
  • avoid excessive heat and humidity
  • tamper evident packets
  • do not use if open or torn

Inactive Ingredients

corn starch, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

Questions or comments?

1-800-430-5490

MM1

Multi Symptom Cold 100CT

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
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:0498-1170-50500 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 - North Safety Products LLC (019777263)
Registrant - North Safety Products LLC (019777263)
Establishment
NameAddressID/FEIOperations
North Safety Products LLC019777263repack(0498-1070, 0498-1170)
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004pack(0498-1070, 0498-1170)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture(0498-1070, 0498-1170)

 
North Safety Products LLC

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Further information

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

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