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NITETIME COUGH


OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each 15 mL = 1 tablespoon): Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine Succinate 6.25 mg


OTC - PURPOSE SECTION

Purpose: Pain reliever/fever reducerCough suppressantAntihistamine


INDICATIONS & USAGE SECTION

Uses

  • Temporarily relieves these common cold/flu symptoms Cough due to minor throat and bronchial irritationRunny nose and sneezingMinor aches and painsHeadacheSore throatFever

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes

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.

  • More than 4 doses in 24 hours, which is the maximum daily amount for this product.
  • With other drugs containing acetaminophen.
  • Adult has 3 or more alcoholic drinks every day while using this product.

OTC - DO NOT USE SECTION

Do not use:

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.

  • 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

  • Glaucoma
  • Liver disease
  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Trouble urinating due to an enlarged prostate gland
  • Persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • Cough that occurs with too much phlegm (mucus)
  • A sodium restricted diet

OTC - WHEN USING SECTION

When using this product

Stop use and ask doctor if

These could be signs of a serious condition

  • Do not exceed recommended dosage
  • Excitability may occur especially in children
  • Marked drowsiness may occur
  • Avoid alcoholic drinks
  • Alcohol, sedatives and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison control center right away.


OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.


DOSAGE & ADMINISTRATION SECTION

Directions:

  • Do not take more than directed.
  • Use enclosed dosing cup.
  • Do not take more than 4 doses in 24-hours.
  • Adults and children 12 years and over: take 2 tablespoons (TBSP) or 30 mL every 6 hours.
  • Children 4 to under 12 years: ask a doctor
  • Children under 4 years: do not use
  • When using other Daytime or Nite time products, carefully read each label to insure correct dosing

STORAGE AND HANDLING SECTION

Other information

  • Store between 15-30 degree Celsius (59-86 degree Fahrenheit)
  • Each tablespoon contains: Sodium 46mg

INACTIVE INGREDIENT SECTION

Inactive ingredients: Alcohol, Anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, High fructose corn syrup, Polyethylene glycol, Propylene glycol, Saccharin sodium, Sodium citrate and Purified Water.


HOW SUPPLIED SECTION

(packs: 4oz, 6oz, 10oz & 12oz) Kingston NDC# 71027-041-06 Manufactured by: Kingston Pharma LLC 5 County Route 42 Massena, NY 13662


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL