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NIGHTTIME

Publix Super Markets Inc

Publix Super Markets, Inc. Nighttime Cough Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 30 mL dose cup)

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Cough suppressant

Antihistamine

NIGHTTIME Uses

temporarily relieves cold symptoms:

  • •cough
  • •runny nose and sneezing

Warnings

Do not use

  • •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

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

  • •do not use more than directed
  • •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

  • •cough lasts for more than 7 days, comes back, or occurs with fever, 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)

Directions

  • •take only as directed
  • •use dose cup
  • •do not exceed 4 doses per 24 hrs

adults and children 12 yrs & over

30 mL (2 TBSP) every 6 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

NIGHTTIME Other information

  • •each 30 mL dose cup contains: sodium 32 mg
  • •store at 20°-25°C (68°-77°F)

Inactive ingredients

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Principal Display Panel

COUGH RELIEF

nighttime

COUGH SUPPRESSANT, ANTIHISTAMINE

DEXTROMETHORPHAN HBr – COUGH

DOXYLAMINE SUCCINATE – SNEEZING, RUNNY NOSE

ALCOHOL 10%

CHERRY FLAVOR

Compare to the active ingredients in Vicks® NyQuil® Cough

12 FL OZ (355 mL)

NIGHTTIME

Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:56062-668
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 30 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 12.5 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
HIGH FRUCTOSE CORN SYRUP
POLYETHYLENE GLYCOLS
propylene glycol
water
saccharin sodium
SODIUM CITRATE

Product Characteristics

Color
RED (Dark Red)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:56062-668-38 296 in 1 BOTTLE
2 NDC:56062-668-40 355 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2003-01-20


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Be sure to consult your doctor before taking any medication!
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