Cold Multi-Symptom Daytime

FRED'S, INC.

Freds 44-560

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each gelcap)
• Purpose
• Cold Multi-Symptom Daytime Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children
• Directions
• Cold Multi-Symptom Daytime Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each gelcap)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Cold Multi-Symptom Daytime Uses

• temporarily relieves these common cold/flu symptoms:
  • minor aches and pains
  • headache
  • nasal congestion
  • cough
  • sore throat
  • sinus congestion and pressure
• helps clear nasal passages
• promotes nasal and sinus drainage
• temporarily reduces fever

Warnings

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

• more than 12 gelcaps 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 2 days, is accompanied or followed by fever, headache, rash, nausea, or comiting, 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

•  liver disease
• diabetes
• heart disease
• high blood pressure
• thyroid disease
• 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)

Ask a doctor or pharmacist before use if

• taking the blood thinning drug warfarin 

When using this product

• do not exceed recommended dosage 

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, or cough gets worse or lasts more than 7 days
• new symptoms occur
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• cough comes back or occurs with rash or headache that lasts

These could be sgins 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see overdose warning)
• adults and children 12 years and over
• take 2 gelcaps every 4 hours
• do not take more than 12 gelcaps in 23 hours
• children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage 

Cold Multi-Symptom Daytime Other information

• store at controlled room temperature 15º-30ºC (59º-86ºF) 
• see end flap for expiration date and lot number

Inactive ingredients

 croscarmellose sodium, crospovidone, D&C red #28, FD&C blue #1, FD&C red #40, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sillica gel, stearic acid, titanium dioxide

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

FRED'S_®

SEE NEW WARNINGS

Cold
Multi-Symptom
Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant

Fever/Headache
Sore Throat - Acetaminophen
Nasal Congestion - Phenylephrine HCl
Coughing - Dextromethorphan HBr

Rapid Release

DAYTIME
24 Gelcaps

Compare To:
The Active Ingredient in Tylenol® Cold Multi-Symptom Daytime Rapid Release Gels*

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Multi-Symptom Daytime Rapid Release Gels.
50844      REV1009A56008