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Publix Super Markets Inc

Publix Super Markets, Inc. Nighttime Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 30 mL dose cup)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

nighttime Uses

temporarily relieves common cold/flu symptoms:

  • •fever
  • •cough due to minor throat and bronchial irritation
  • •sore throat
  • •minor aches and pains
  • •runny nose and sneezing
  • •headache

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (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 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, 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.
  • •if you have ever had an allergic reaction to this product or any of its ingredients
  • •to make a child sleepy

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

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

When using this product

  • •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

  • •redness or swelling is present
  • •pain or cough gets worse or lasts more than 7 days
  • •fever gets worse or lasts more than 3 days
  • •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.

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
  • •use dose cup
  • •do not exceed 4 doses per 24 hrs

adults & 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 39 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

Package/Label Principal Display Panel

COLD & FLU

nighttime

PAIN RELIEVER, FEVER REDUCER, COUGH SUPPRESSANT, ANTIHISTAMINE

ACETAMINOPHEN – ACHES, FEVER, SORE THROAT

DEXTROMETHORPHAN HBr – COUGH

DOXYLAMINE SUCCINATE – SNEEZING, RUNNY NOSE

ALCOHOL 10%

CHERRY FLAVOR

Compare to the active ingredients in Vicks® NyQuil®

12 FL OZ (355 mL)

nighttime

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:56062-459
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg
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 (Clear/Dark Red)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:56062-459-40 355 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-11-07


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