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

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Night Time Gelcap

Kareway Product, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients(in each GelCap)

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Night Time Gelcap Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

Warnings

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.
  • to make a child sleep

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • cough that occurs with too much phegm(mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

Enter section text here

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 7 days
  • 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

Enter section text here

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

Night Time Gelcap Other information

  • store at room temperature

Inactive ingredients

FDC yellow no. 5, dioxide, FDC blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sobital special

Pure-Aid Nighttime GelcapNight Time Gelcap

Night Time Gelcap

Acetaminophen, Dextromethorphan, Doxylamine CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67510-0521
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
DOXYLAMINE SUCCINATE DOXYLAMINE 5 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
GELATIN
GLYCERIN
polyethylene glycol 400
povidone
PROPYLENE GLYCOL, (R)-
water
sorbitol

Product Characteristics

Color Size Imprint Code Shape
green 24 mm NYTIME 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:67510-0521-4 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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