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
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporarily relieves
  • sinus congestion and pressure
  • headache
  • minor aches and pains
  • nasal congestion

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
• 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 the recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain or nasal congestion gets worse or lasts more than 7 days
• redness or swelling is present
• fever gets worse or lasts more than 3 days
• 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

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

• do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 caplets every 4 hours 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

Other Information

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

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6, hypromellose, lactose anhydrous, magnesium stearate, methylparaben, povidone, pregelatinized starch, propylene glycol, propylparaben, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

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

Principal Display Panel - 24 Caplet Blister Pack Carton

RESTORE u

NDC 57344-154-02

^†COMPARE TO THE ACTIVE ACTIVE INGREDIENTS IN SINUTAB ^® SINUS

NON-DROWSY

Maximum Strength Sinus Relief

Pain Reliever, Nasal Decongestant Acetaminophen, Phenylephrine HCI

Relieves: • Headache • Nasal Congestion • Sinus Presssure & Pain

24 CAPLETS