FDA Label for Vicks Flu Therapy Severe Cold And Flu Day

Other

Drug Facts

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

Otc - Active Ingredient

Acetaminophen 500 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg

Otc - Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

• minor aches & pains
• sore throat
• fever
• headache
• cough due to minor throat & bronchial irritation
• cough to help you sleep
• nasal congestion
• sinus congestion & pressure
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage

Liver Warning

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

• more than 6 doses in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy Alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

• Skin reddening
• Blisters
• Rash

If a skin reaction occurs, stop use and seek medical help right away

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.

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.

Ask A Doctor Before Use If You Have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• cough that occurs with too much phlegm (mucus)
• persostent or chronic cough such as occurs with smoking, asthma, or emphysema
• trouble urinating due to enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

When Using This Product

do not use more than directed

Stop Use And Ask A Doctor If

• you get nervous, dizzy or sleepless
• pain, nasal congestion, 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away. 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
• do not exceed 6 doses per 24 hrs

adults & children 12 yrs & over one packet every 4 hrs
children under 12 yrs do not use

• Dissolve contents of one packet into 8 oz. of hot water and stir briskly; sip while hot. Consume entire drink within 10-15 minutes
• If using a microwave, add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat

Other Information

• potassium 10 mg
• phenylketonurics: contains phenylalanine 64 mg per dose
• do not exceed 25°C.

Inactive Ingredients

acesulfame potassium, aspartame, carboxymethylcellulose, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, flavors, sucrose, tribasic calcium phosphate

Questions?

1-800-362-1683

Principal Display Panel - 6 Packet Backer Card And Insert

VICKS ®

DAY

FLUTherapy

SEVERE COLD & FLU

Acetaminophen - Pain Reliever/Fever reducer, Dextromethorphan HBr -

Cough suppressant Phenylephrine HCl - Nasal decongestant

Soothing Vapors +

Relieves:

• Nasal Congestion
• Sore Throat
• Body Aches
• Fever
• Cough


HoneyLemon Flavor


6 PACKETS

Day - Day