FDA Label for Nitetime Cough

Otc - Active Ingredient

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

Otc - Purpose

Purpose:
Pain reliever/fever reducer
Cough suppressant
Antihistamine

Indications & Usage

Uses

• Temporarily relieves these common cold/flu symptoms
  • Cough due to minor throat and bronchial irritation
  • Runny nose and sneezing
  • Minor aches and pains
  • Headache
  • Sore throat
  • Fever
  
  

Warnings

Warnings

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

• 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.

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.

Otc - Do Not Use

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.

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

Otc - Ask Doctor

Ask a doctor before use if you have

• 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

Ask a doctor or pharmacist before use if you are

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

Otc - When Using

When using this product

• 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

Stop use and ask doctor if

• Cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts.

These could be signs of a serious condition

Otc - Keep Out Of Reach Of Children

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

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

Dosage & Administration

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

Other information

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

Inactive Ingredient

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

(packs: 4oz, 6oz, 10oz & 12oz) Kingston NDC# 71027-041-06

Manufactured by: Kingston Pharma LLC
5 County Route 42
Massena, NY 13662