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NITE TIME COLD AND FLU (acetaminophen 325 mg dextromethorphan hydrobromide 15 mg doxylamine succinate 6.25 mg) Dailymed

  1. Human OTC
  2. Archived
  3. PuraVation Pharmaceuticals Inc

Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate

NITE TIME COLD AND FLU solution - (acetaminophen 325 mg dextromethorphan hydrobromide 15 mg doxylamine succinate 6.25 mg) image

IMPRINT: PC10     SHAPE: capsule
    COLOR: green

  1. FDA Adverse Reactions

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Active Ingredients (in Each Softgel)


Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine Succinate 6.25 mg

Purpose


Pain reliever/fever reducer

Cough suppressant 

Antihistamine

Uses


temporarily relieves common cold/flu symptoms:
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches/pains
  • fever
  • runny nose & 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
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Otc - Do Not Use Section


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
  • heart disease
  • asthma
  • emphysema
  • thyroid disease
  • diabetes
  • glaucoma
  • high blood pressure
  • cough with excessive phlegm(mucus)
  • breathing problems
  • chronic bronchitis
  • persistent or chronic cough
  • cough associated with smoking
  • difficulty in urinating due to an 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 exceed the recommended dosage
  • do not use with other products containing acetaminophen
  • do not use for more than 7 days
  • excitability may occur especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Otc - Stop Use Section


Stop use and Ask a doctor if
  • you get nervous, dizzy, or sleepless
  • swelling or redness is present
  • symptoms do not get better or are accompanied by a fever that lasts more than 3 days or if new symptoms occur
  • cough lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache.

These may be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding Section


If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children Section


Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

  • take only as recommended - see overdose warning
  • do not exceed 4 doses per 24 hours

Adults and children 12 years of age and older
  Swallow 2 softgels with water every 6 hours

Children 4 to 12 years of age
  ask a doctor

children under 4 years of age
  do not use

If taking NITE TIME and DAY TIME softgels carefully read each label to insure correct dosing.

Other Information

  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
  • this product does not contain phenylpropanolamine (PPA)

Inactive Ingredients


D&C Yellow # 10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, and white edible ink

OTC - QUESTIONS SECTION


Questions or comments? Call toll free: 1-800-833-6278

Principal Display Panel


NITE TIME

LIQUID CAPS

ADULT NIGHTTIME COLD/FLU MEDICINE

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

PAIN RELIEVER, FEVER REDUCER, COUGHT SUPPRESSANT, ANTIHISTAMINE

Compare to the active ingredients in Vicks® NyQuil®



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