Acetaminophen, Phenylephrine Hydrochloride (acetaminophen 325 mg phenylephrine hydrochloride 5 mg) Dailymed

Otc - Active Ingredient Section

OTC - PURPOSE SECTION

Active ingredients (in each caplet)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
  • headache
  • sinus congestion and pressure
  • nasal congestion
  • minor aches and pains
• helps decongest sinus openings and passages
• promotes sinus drainage
• helps clear nasal passages
• temporarily reduces fever

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 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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage

OTC - STOP USE SECTION

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain or nasal congestion 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

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

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

• 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

Other Information

• store between 20-25°C (68-77°F) in a dry place
• retain carton for complete product information

Inactive Ingredients

acesulfame potassium, colloidal silicon dioxide,croscarmellose sodium, D&C yellow #10, FD&C blue #1, flavor, hypromellose, lactose, magnesium stearate, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Distributed by: AAA Pharmaceutical, Inc. 681 Main Street Lumberton, NJ 08048

Principal Display Panel - 24 Tablet Blister Pack Carton

RESTORE u

NDC 57344-123-05

^†COMPARE TO THE ACTIVE INGREDIENTS IN TYLENOL ^® SINUS CONGESTION & PAIN - DAYTIME

See New Warnings Information & Directions

DAY TIME NON-DROWSY

Sinus For Adults CONGESTION & PAIN Pain Reliever/Fever Reducer, Nasal Decongestant

• Sinus Headache – Acetaminophen
• Nasal Congestion/Sinus Pressure – Phenylephrine HCl

24 CAPLETS