Leader Nite Time

Cardinal Health

Cardinal Health Nite·Time Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each softgel)
• Purpose
• Leader Nite Time Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Leader Nite Time Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 8 softgels (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.
• •to make a child sleepy
• •if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

• •liver disease
• •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
• •taking the blood thinning drug warfarin

When using this product

• •excitability may occur, especially in children
• •be careful when driving a motor vehicle or operating machinery
• •avoid alcoholic drinks
• •alcohol, sedatives and tranquilizers may increase drowsiness
• •may cause marked drowsiness

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.

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
• •do not exceed 8 softgels per 24 hours

• •when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
•  

Inactive ingredients

D&C yellow no. 10, edible ink, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-800-719-9260

Principal Display Panel

SEE NEW WARNINGS AND DIRECTIONS

Compare to Vicks® NyQuil® LiquiCaps® active ingredients

Nite·Time

Cold & Flu

Multi-Symptom Relief

Antihistamine - Cough Suppressant

Fever Reducer - Pain Reliever

Acetaminophen – aches, fever

Dextromethorphan HBr – cough

Doxylamine Succinate – sneezing, runny nose

ALCOHOL FREE