daytime nitetime cold and flu description, usages, side effects, indications, overdosage, supplying and lots more!

daytime nitetime cold and flu

Meijer Distribution Inc

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Meijer Distribution, Inc. DayTime NiteTime Cold & Flu 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

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

Questions or comments?

1-800-719-9260

Principal Display Panel - Nighttime

Compare to Vicks® NyQuil® Cold & Flu active ingredients

Liquid Capsules

Nitetime Cold & Flu

Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

Multi-Symptom Relief

Alcohol Free

Relief of: aches, fever, cough, sneezing & runny nose

16 Softgels

Principal Display Panel - Daytime

Compare to Vicks® DayQuil® Cold & Flu active ingredients.

Non-Drowsy

DayTime Cold & Flu

Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

Multi-Symptom Relief

Alcohol Free/Antihistamine Free

Relief of: aches, fever, cough & nasal congestion

32 Softgels

daytime nitetime cold and flu

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41250-090
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41250-090-72 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-02-11


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Be sure to consult your doctor before taking any medication!
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