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NiteTime

Greenbrier International

NiteTime Multi-Symptom Liquid Capsules Cold/Flu Relief


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

NiteTime Uses

temporarily relieves common cold/flu symptoms

  • cough due to minor throat and 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 for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

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, see 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 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, & tranquilizers may 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. 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.

Overdose warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hrs
Adults & children 12 years and over 2 softgels with water every 6 hrs
Children 4 to under 12 years ask a doctor
Children under 4 years do not use

NiteTime Other information

  • store at room temperature

Inactive ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, purified water, sorbitol, titanium dioxide

Questions?

1-866-467-2748

This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® Nyquil® Cold & Flu Liquicaps®

PRINCIPAL DISPLAY PANEL - 10 Softgel Carton

Assured

Multi-Symptom

NiteTime

Acetaminophen, Doxylamine, Dextromethorphan HBr

Cold/Flu Relief

  • Aches & Sore Throat
  • Sneezing, Runny Nose
  • Cough

    10 Softgels

NiteTime

NiteTime

Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:33992-0621
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 6.25 mg

Inactive Ingredients

Ingredient Name Strength
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
GLYCERIN
METHYLPARABEN
POLYETHYLENE GLYCOLS
POVIDONES
propylene glycol
PROPYLPARABEN
water
sorbitol
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
GREEN 21 mm RP062 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:33992-0621-0 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-01-04


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Be sure to consult your doctor before taking any medication!
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