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Cold (acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / phenylephrine hydrochloride 5 mg oral tablet) Dailymed

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

Generic: acetaminophen, dextromethorphan hbr, phenylephrine hcl

Cold tablet - (acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / phenylephrine hydrochloride 5 mg oral tablet) image
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acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / phenylephrine hydrochloride 5 mg oral tablet - l 0 oval red

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Active Ingredients (in Each Gelcap)


Acetaminophen 325 mgDextromethorphan HBr 10 mgPhenylephrine HCl 5 mg

Purpose


Pain reliever/fever reducerCough suppressantNasal decongestant

Uses

  • temporarily relieves these common cold/flu symptoms:
    • headache
    • sinus congestion and pressure
    • nasal congestion
    • cough
    • sore throat
    • minor aches and pains
  • helps clear nasal passages
  • promotes nasal and sinus drainage
  • temporarily reduces fever

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:
  • skin reddening 
  • bulers 
  • rash

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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)

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, nasal congestion, or cough 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
  • persistent cough lasts for more than one week , tends to recur, or is accompanied by fever, rash, or persistent headache

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 gelcaps every 4 hours
    • do not take more than 10 gelcaps 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
  • avoid high humidity
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) 
  • see end flap for expiration date and lot number

Inactive Ingredients


croscarmellose sodium, crospovidone, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silica gel, stearic acid, titanium dioxide

Questions Or Comments?


1-800-426-9391

Principal Display Panel


fred'sPharmacy

NDC 55315-560-08

Daytime Non-Drowsy                

Cold                                                                  Multi-Symptom

Acetaminophen 325 mg - Pain Reliever/Fever Reducer  Dextromethorphan HBr 10 mg - Cough SuppressantPhenylephrine HCl 5 mg - Nasal Decongestant

• Fever • Headache • Coughing• Sore Throat • Nasal Congestion

24 Rapid ReleaseGelcaps

Actual Size

Compare to the  active ingredients in: Tylenol® COLD MAX day*

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 38118www.fredsinc.com

100% satisfaction           guaranteed Questions or comments? 1-855-331-FRED (3733)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® COLD MAX day.50844      REV0216C56008
Freds pharmacy 44-560

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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