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

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Night Time Cold/Flu Relief Original

Kareway Product, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 15 ml tablespoon)


Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Night Time Cold/Flu Relief Original Uses


  • 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 hours 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:

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 phlegm (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

  • do not use more than directed
  • excitability may occur, especially in children.
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers increase drowsiness

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.

If pregnant or breast-feeding,


Keep out of reach of children.



Overdose warning:

Directions

  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hours

adults and children 12 yrs and over
30 ml (2 Tbsp) every 6 hours
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use

Night Time Cold/Flu Relief Original Other information

  • each 30 mL dose cup contains: sodium 43 mg
  • store at room temperature

Inactive ingredients

alcohol, citric acid, FD and C blue no.1, FD and C yellow no.5, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose, sucralose

Package label

Night Time Cold/Flu Relief OriginalNight Time Cold/Flu Relief Original

Night Time Cold/Flu Relief Original

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67510-0501
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 6.25 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
CITRIC ACID MONOHYDRATE
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
HIGH FRUCTOSE CORN SYRUP
POLYETHYLENE GLYCOLS
propylene glycol
water
saccharin sodium
SODIUM CITRATE
SUCROSE
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67510-0501-4 120 in 1 BOTTLE
2 NDC:67510-0501-6 177 in 1 BOTTLE
3 NDC:67510-0501-0 295 in 1 BOTTLE
4 NDC:67510-0501-2 354 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-08-26


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