Non-Aspirin Sinus Congestion and Pain

FRED'S, INC.

Freds 44-455C

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purpose
• Non-Aspirin Sinus Congestion and Pain 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
• Non-Aspirin Sinus Congestion and Pain Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Antihistamine
Nasal decongestant

Non-Aspirin Sinus Congestion and Pain Uses

• temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • sinus congestion and pressure

  • nasal congestion

  • runny nose and sneezing

  • headache

  • minor aches and pains

• temporarily relieves these additional symptoms of hay fever:

  • itching of the nose or throat

  • itchy, watery eyes

• helps clear nasal passages

• helps decongest sinus openings and passages

Warnings

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

• more than 12 caplets 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

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

• diabetes

• heart disease

• high blood pressure

• thyroid disease

• trouble urinating due to an enlarged prostate gland

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers

When using this product

• do not exceed recommended dosage

• excitability may occur, especially in children

• drowsiness may occur

• alcohol, sedatives, and tranquilizers may increase drowsiness

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur

• pain or nasal congestion 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

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. 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 caplets every 4 hours

  • swallow whole - do not crush, chew, or dissolve

  • do not take more than 12 caplets in 24 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

Non-Aspirin Sinus Congestion and Pain Other information

• store at controlled room temperature 15°-30°C (59°-86°F)

• see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

Fred's®

Nighttime
Pseudoephedrine Free

Acetaminophen, Chlorpheniramine maleate
Phenylephrine HCl 10 mg

Pain Reliever, Antihistamine,
Nasal Decongestant

Headache, Sinus Pressure
Nasal Congestion, Runny Nose

24 Cool Caplets
with Cool Blast Flavor

Compare to the active ingredients in:
Tylenol® Sinus Congestion & Pain Nighttime*

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® Sinus Congestion & Pain.
50844      REV0612E45508