Day Time Gelcap description, usages, side effects, indications, overdosage, supplying and lots more!

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Day Time Gelcap

Kareway Product, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients(in each GelCap)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Day Time Gelcap 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 you take

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

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 to adults and children even if you do not notice any signs or symptoms.


Directions

  • take only as directed-see Overdose warning
  • do not exceed 4 doses per 24 hours
    adults and children 12 yrs and over
    2 GelCaps with water every 6 hrs
    children 4 to under 12 yrs
    ask a doctor
    children under 4 yrs
    do not use

Day Time Gelcap Other information

  • store at room temperature

Inactive ingredients

FDC red no. 40, FDC yellow no. 5, dioxide, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sobital special

Daytime gelcapDay Time Gelcap

Day Time Gelcap

Acetaminophen, Dextromethorphan, Phenylephrine CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67510-0523
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
FD&C RED NO. 40
FD&C YELLOW NO. 5
GELATIN
GLYCERIN
polyethylene glycol
povidone
PROPYLENE GLYCOL, (R)-
water
sorbitol

Product Characteristics

Color Size Imprint Code Shape
orange 24 mm DYTIME CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 12 in 1 BLISTER PACK
3 20 in 1 BLISTER PACK
4 24 in 1 BLISTER PACK
5 NDC:67510-0523-4 2 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-06-01


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