Day Time Cold/Flu Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Day Time Cold/Flu Relief

Kareway Product, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients(in each 15 ml tablespoon)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Day Time Cold/Flu Relief 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 are


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

Day Time Cold/Flu Relief 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 ReliefDay Time Cold/Flu Relief

Day Time Cold/Flu Relief

Acetaminophen, Dextromethorphan, Phenylephrine LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67510-0544
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
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:67510-0544-4 120 in 1 BOTTLE
2 NDC:67510-0544-6 177 in 1 BOTTLE
3 NDC:67510-0544-0 295 in 1 BOTTLE
4 NDC:67510-0544-2 354 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-09-06


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