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Sinus Congestion and Pain (acetaminophen 325 mg chlorpheniramine maleate 2 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Archived
  3. FRED'S, INC.

Generic: acetaminophen, chlorpheniramine maleate and phenylephrine hcl

Sinus Congestion and Pain tablet, film coated - (acetaminophen 325 mg chlorpheniramine maleate 2 mg phenylephrine hydrochloride 5 mg) image

  1. FDA Adverse Reactions

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Active Ingredients (in Each Caplet)


Acetaminophen 325 mgChlorpheniramine maleate 2 mgPhenylephrine HCl 5 mg

Purpose


Pain reliever/fever reducerAntihistamineNasal decongestant

Uses

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

Warnings


Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • more than 4,000 mg 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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
  • bulers
  • rash
  • skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

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

  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • diabetes
  • glaucoma
  • high blood pressure
  • a breathing problem such as emphysema or chronic bronchitis
  • heart disease
  • thyroid disease

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
  • may cause drowsiness

Stop use and ask a doctor if

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

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.


In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
  • 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

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive Ingredients


corn starch, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments?


1-800-426-9391

Principal Display Panel


fred'sPharmacy

NDC 55315-455-08

Nighttime

SINUS CONGESTION & PAIN

Acetaminophen, Chlorpheniramine maleate,Phenylephrine HCl

Pain Reliever/Fever Reducer, Antihistamine, Nasal Decongestant

Pseudoephedrine Free

 • Headache                   • Sinus Pressure, • Runny Nose           • Nasal Congestion

24 Cool Caplets with Cool Blast Flavor

Compare to the active ingredients in: Tylenol® Sinus Congestion & Pain Nighttime*

TAMPER EVIDENT: DO NOT USE IF PACKAGE ISOPENED OR IF BLISTER UNIT IS TORN, BROKENOR SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY: fred's, Inc.4300 NEW GETWELL RD, MEMPHIS, TN 38118 www.fredsinc.com

100% satisfaction guaranteed

*This product is not manufactured or distributed by McNeilConsumer Healthcare, owner of the registered trademarkTylenol® Sinus Congestion & Pain Nighttime.50844          REV0616G45508
Freds 44-455C

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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