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Day Time Cold/Flu Relief by Kareway Product, Inc.

Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: Kareway Product, Inc.
NDC Code: 67510-0544

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.

Drug Facts

Active ingredients(in each 15 ml tablespoon)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • nasal decongestion
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever

Warnings

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Liver warning

This product contains acetaminophen.  Severe liver damage may occur if adult/child takes

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Sore throat warning:

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phegm(mucus)
  • Persistent or chronic cough as occurs with smoking, asthma, emphysema
  • a sodium-restricted diet

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

When using this product, do not use more than directed.


Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • 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.

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Overdose warning:

Taking more than directed can cause serious health problems.  In case of overdose, get medical help or contact a Poison Control Center right away.  Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms.


Directions
  • take only as directed-see Overdose warning
  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
    adults and children 12 yrs and over
    30 ml (2 TBSP) every 6 hours
    children 6 to under 12 yrs
    15 ml (1 TBSP) every 4 hours
    children 4 to under 6 yrs
    ask a doctor
    children under 4 yrs
    do not use

Other information
  • each tablespoon contains: sodium 50mg
  • store at room temperature

Inactive ingredients

citric acid, FDC red no.40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium,
sodium citrate, sucralose, sucrose, xanthan gum

Daytime Cold/Flu Relief

DAY TIME COLD/FLU RELIEF 
acetaminophen, dextromethorphan, phenylephrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0544
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SODIUM CITRATE 
SUCROSE 
SUCRALOSE 
SACCHARIN SODIUM DIHYDRATE 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:67510-0544-4120 mL in 1 BOTTLE
2NDC:67510-0544-6177 mL in 1 BOTTLE
3NDC:67510-0544-0295 mL in 1 BOTTLE
4NDC:67510-0544-2354 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/06/2011
Labeler - Kareway Product, Inc. (121840057)

 
Kareway Product, Inc.

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Medically reviewed on Jul 11, 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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