Cold Head Congestion Daytime

FRED'S, INC.

Freds 44-470C

FULL PRESCRIBING INFORMATION: CONTENTS*

• 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.
• Principal display panel

FULL PRESCRIBING INFORMATION

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant 

• temporarily relieves these common cold symptoms:
  • minor aches and pains
  • headache
  • nasal congestion
  • cough
  • sore throat
  • sinus congestion and pressure
• helps clear nasal passages

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damagae 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 using this product. 

Ask a doctor before use if you have

• 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 you are

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 appear
• fever gets worse or lasts more than 3 days
• redness or swelling is presesnt
• 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 (1-800-222-1222) right away.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

• do not take more than directed
  (see overdose warning)
• adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole - do not crush, chew, or dissolve
  • do not take more than 10 caplets in 24 hours
• children under 12 years: ask a doctor

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86º)
• see end flap for expiration date and lot number 

corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, sucralose, talc, titanium dioxide 

Principal display panel

fred's®

Daytime
Pseudoephedrine Free

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

Pain Reliever,
Nasal Decongestant,
Cough Suppressant           

Compare To The Active Ingredient in: Head Congestion Daytime Tylenol® Cold Head Congestion Daytime*

24 Cool Caplets
with Cool Blast Flavor

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 Head Congestion Daytime.
50844      REV0113E47008

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38818
www.fredsinc.com