All-Nite Cold and Flu

Major Pharmaceuticals

Meijer Distribution, Inc. Nite Time Cold & Flu Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 30 mL dose cup)
• Purpose
• All-Nite Cold and Flu 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
• All-Nite Cold and Flu Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (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

All-Nite Cold and Flu Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4 doses (2,600 mg acetaminophen) in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or 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
• a sodium-restricted diet
• cough that occurs with too much phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

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

When using this product

• avoid alcoholic drinks
• excitability may occur, especially in children
• marked drowsiness may occur
• 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
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
• new symptoms occur

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 hours

• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
• each 30 mL dose cup contains: sodium content: 38 mg

All-Nite Cold and Flu Other information

• each 30 mL dose cup contains: sodium 38 mg
• store at 20°-25°C (68°-77°F)

Inactive ingredients

alcohol, citric acid, flavor, FD&C greeen no. 3, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, FD&C yellow no. 6, FD&C yellow no. 10

Questions or comments?

1-800-616-2471

Principal Display Panel

Compare to Vicks® NyQuil® Cold & Flu active ingredients

SEE NEW WARNINGS INFORMATION

Original Flaror

All-Nite Cold & Flu

Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

Multi Symptom Relief

Acetaminophen - aches, fever

Dextromethorphan HBr - cough

Doxylamine Succinate - sneezing, runny nose

ALCOHOL 10%