Severe Cold and Flu

HyVee Inc

Hy-Vee, Inc. Severe Cold & Flu Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purpose
• Severe 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
  • Severe Cold and Flu Other information
• Inactive Ingredients
  • Questions or comments?
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Severe Cold and Flu Uses

• •temporarily relieves common cold/flu symptoms:
• •sinus congestion and pressure
• •cough due to minor throat and bronchial irritation
• •minor aches and pains
• •nasal congestion
• •headache
• •fever
• •sore throat
• •temporarily restores freer breathing through the nose
• •reduces swelling of nasal passages
• •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• •promotes nasal and/or sinus drainage

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 8 caplets (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, 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.
• •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
• •heart disease
• •diabetes
• •high blood pressure
• •thyroid disease
• •trouble urinating due to an enlarged prostate gland
• •cough that occurs with too much phlegm (mucus)
• •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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

• •fever gets worse or lasts more than 3 days
• •pain, nasal congestion or cough gets worse or lasts more than 7 days
• •you get nervous, dizzy or sleepless
• •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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 Overdose warning
• •do not exceed 8 caplets per 24 hours

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

Other information

• •each caplet contains: sodium 4 mg

Inactive Ingredients

croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the Active Ingredients of Vicks® DayQuil® Severe Cold & Flu Caplets

Max Strength

Severe Cold & Flu

PAIN RELIEVER/FEVER REDUCER, NASAL DECONGESTANT, COUGH SUPPRESSANT, EXPECTORANT

Day Time

Non-Drowsy

Aches, Fever, Sore Throat – Acetaminophen

Nasal Congestion – Phenylephrine HCl

Coughing – Dextromethorphan HBr

Chest Congestion – Guaifenesin

Alcohol Free/Antihistamine Free

24 Caplets