rexall daytime nighttime description, usages, side effects, indications, overdosage, supplying and lots more!

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rexall daytime nighttime

Dolgencorp Inc

Dolgencorp, LLC DayTime NightTime Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients for Nighttime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Active ingredient for Daytime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

rexall daytime nighttime Uses

temporarily relieves common cold/flu symptoms:

  • •cough due to minor throat and bronchial irritation
  • •sore throat
  • •headache
  • •minor aches and pains
  • •fever
  • •relieves runny nose and sneezing (Nighttime only)
  • •nasal congestion (Daytime only)

Warnings

Liver warning: These products contain acetaminophen. The maximum daily dose of these products is 8 softgels (2,600 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

  • •more than 4,000 mg of acetaminophen in 24 hours
  • •with other drugs containing acetaminophen
  • •3 or more alcoholic drinks every day while using these products

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, consult 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 these products.
  • •to make a child sleepy (Nighttime only)
  • •if you have ever had an allergic reaction to these products or any of their ingredients

Ask a doctor before use if you have

  • •liver disease
  • •heart disease (Daytime only)
  • •thyroid disease (Daytime only)
  • •diabetes (Daytime only)
  • •high blood pressure (Daytime only)
  • •cough that occurs with too much phlegm (mucus)
  • •a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
  • •persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • •trouble urinating due to an enlarged prostate gland
  • •glaucoma (Nighttime only)

Ask a doctor or pharmacist before use if you are

  • •taking sedatives or tranquilizers (Nighttime only)
  • •taking the blood thinning drug warfarin

When using these products

  • •do not use more than directed

In addition, when using Nighttime:

  • •excitability may occur, especially in children
  • •may cause marked drowsiness
  • •avoid alcoholic drinks
  • •be careful when driving a motor vehicle or operating machinery
  • •alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • •you get nervous, dizzy or sleepless (Daytime only)
  • •redness or swelling is present
  • •fever gets worse or lasts more than 3 days
  • •new symptoms occur
  • •pain, nasal congestion or cough gets worse or lasts more than 7 days
  • •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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • •take only as directed - see Liver warning
  • •take Nighttime OR Daytime

Nighttime Softgels

  • •do not exceed 8 softgels per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Daytime Softgels

  • •do not exceed 8 softgels per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

  • •when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information

  • •store at 20°-25°C (68°-77°F)

Inactive ingredients

Nighttime D&C yellow no. 10, edible ink, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Daytime edible ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Principal Display Panel

NON-DROWSY

Daytime

Cold/Flu

ALCOHOL-FREE & ANTIHISTAMINE-FREE

ACETAMINOPHEN – Pain reliever/Fever reducer

DEXTROMETHORPHAN HBr – Cough suppressant

PHENYLEPHRINE HCl – Nasal decongestant

For relief of

aches, fever, cough

nasal congestion

SEE NEW WARNINGS AND DIRECTIONS

Nighttime

Cold/Flu

ACETAMINOPHEN – Pain reliever/Fever reducer

DEXTROMETHORPHAN HBr – Cough suppressant

DOXYLAMINE SUCCINATE – Antihistamine

For relief of

aches, fever, cough

sneezing, runny nose

SEE NEW WARNINGS AND DIRECTIONS

COMBO PACK

rexall daytime nighttime

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55910-167
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55910-167-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-09-14


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Be sure to consult your doctor before taking any medication!
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