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ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE - acetaminophen and phenylephrine hydrochloride tablet, coated 
AAA Pharmaceutical, Inc.

Acetaminophen, Phenylephrine HCl Tablets

Drug Facts

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

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

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

Principal Display Panel - 24 Tablet Blister Pack Carton

ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE 
acetaminophen and phenylephrine hydrochloride  tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 57344-123
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM  
SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
HYPROMELLOSES  
LACTOSE  
MAGNESIUM STEARATE  
POVIDONES  
STARCH, CORN  
PROPYLENE GLYCOL  
SODIUM STARCH GLYCOLATE TYPE A CORN  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color GREEN Score no score
Shape OVAL Size 17mm
Flavor MINT Imprint Code AAA;1114
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 57344-123-02 2  In 1 CARTON contains a BLISTER PACK
1 12  In 1 BLISTER PACK This package is contained within the CARTON (57344-123-02)
2 57344-123-03 4  In 1 CARTON contains a BLISTER PACK
2 12  In 1 BLISTER PACK This package is contained within the CARTON (57344-123-03)
3 57344-123-05 2  In 1 CARTON contains a BLISTER PACK
3 12  In 1 BLISTER PACK This package is contained within the CARTON (57344-123-05)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 12/28/2012

Labeler - AAA Pharmaceutical, Inc. (181192162)
Revised: 01/2013AAA Pharmaceutical, Inc.