Acetaminophen, Phenylephrine Hydrochloride

AAA Pharmaceutical, Inc.

Acetaminophen, Phenylephrine HCl Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

• Acetaminophen, Phenylephrine Hydrochloride Uses
• Warnings
  • Liver warning
  • Overdose warning
• Directions
• Acetaminophen, Phenylephrine Hydrochloride Other information
• Inactive ingredients
• PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Acetaminophen, Phenylephrine Hydrochloride 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

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

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

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 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.

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

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)

Acetaminophen, Phenylephrine Hydrochloride 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