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DayTime Nite Time

Kroger Company

Kroger Co. DayTime Nite Time Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient for NIGHTTIME (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredient for DAYTIME (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose (NIGHTTIME ONLY)

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose (DAYTIME ONLY)

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

DayTime Nite Time Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion (DAYTIME ONLY)
  • sore throat
  • headache
  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • fever
  • relieves runny nose and sneezing (NIGHTTIME ONLY)

Warnings

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take

  • more than 8 softgels in 24 hours (Nighttime) or more than 12 softgels in 24 hours (Daytime), which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using these products

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or 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 this product.
  • to make a child sleepy

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • 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
  • marked drowsiness may occur
  • 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
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • 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 recommended - see Liver warning
  • take Nighttime OR Daytime

NIGHTTIME SOFTGELS

  • do not exceed 4 doses per 24 hours
adults and children 12 years and over

2 softgels with water every

6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

DAYTIME SOFTGELS

  • do not exceed 6 doses per 24 hours
adults and children 12 years and over

2 softgels with water every

4 hours
children 4 to under 12 years ask a doctor
children under 4 years 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, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

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

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO active ingredients of DAYQUIL® LIQUICAPS®

See top panel

ALCOHOL & ANTIHISTAMINE FREE

SEE NEW WARNINGS INFORMATION

Multi-Symptom

Cold/Flu Relief

Non-Drowsy

DayTime

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Phenylephrine HCl – Nasal Decongestant

Aches/Fever

Cough

Nasal Congestion

Save when you buy Day Time and Nite Time!

COMPARE TO active ingredients of NYQUIL® LIQUICAPS®

See top panel

SEE NEW WARNINGS INFORMATION

Multi-Symptom

Cold/Flu Relief

Nite Time

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Doxylamine Succinate – Antihistamine

Aches/Fever

Cough

Sneezing/Runny Nose

DayTime Nite Time
DayTime Nite Time Carton Image 1 DayTime Nite Time Carton Image 2

DayTime Nite Time

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-090
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:30142-090-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-08-31


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Be sure to consult your doctor before taking any medication!
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