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Nite time

McKesson (Sunmark)

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Nite time Uses

  • temporarily relieves common cold and flu symptoms:
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing
    • cough due to minor throat and bronchial irritation

Warnings

Liver warning: This product contains acetaminophen. 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 this product

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

  • to make a child sleep
  • 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.

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

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 the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 6 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use
  • when using other day time or nite time products, carefully read each label to insure correct dosing

Nite time Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat

Inactive ingredients

D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO VICKS® NYQUIL® LIQUICAPS® ACTIVE INGREDIENTS†

Nite Time Cold & Flu Relief

Relieves cold and flu symptoms so you can rest

Pain reliever, Fever reducer, Cough suppressant, Antihistamine

aches, fever, sore throat...ACETAMINOPHEN

cough...DEXTROMETHORPHAN HBr

sneezing, runny nose...DOXYLAMINE SUCCINATE

MULTI-SYMPTOM

SOFTGELS

Another Quality Product Distributed by McKesson

One Post Street, San Francisco, CA 94104

www.sunmarkbrand.com

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® NyQuil® LiquiCaps®.

Product Label

Nite time
Sunmark Nite Time Cold & Flu Softgel

Nite time

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49348-741
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
POLYETHYLENE GLYCOLS
POVIDONES
propylene glycol
water
SORBITAN
sorbitol

Product Characteristics

Color Size Imprint Code Shape
GREEN 20 mm P30;94A;35A CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 8 in 1 BLISTER PACK
3 10 in 1 BLISTER PACK
4 NDC:49348-741-47 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-07-18


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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