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



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    COLOR: orange

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Drug Facts

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

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

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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