Circle K® Cold

Circle K® Cold

Drug Labeling and Warnings

Drug Details

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CIRCLE K COLD- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet 
Lil' Drug Store Products, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Circle K® Cold

Drug Facts

Active ingredients (in each tablet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

  • for the temporary relief of the following cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
    • impulse to cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. 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.

Allergy alert

Acetaminophen may cause severe allergic reactions. Symptoms may include:

  • skin reddening
  • blisters
  • 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.

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

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
  • diabetes
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

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

  • pain, nasal congestion or cough 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
  • cough comes back or is accompanied by a fever, rash or persistent headache
  • nervousness, dizziness, or sleeplessness 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. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt 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 tablets with water every 6-8 hours as needed
  • do not take more than 8 tablets in 24 hours, or as directed by a doctor
children under 12 years of ageask a doctor

Other information

  • store at room temperature 59-86° F (15-30° C)

Inactive ingredients

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide1, sodium starch glycolate, starch, stearic acid


  • 1 may contain
  • Questions or comments?

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    Proudly distributed by Circle K Stores Inc.

    PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton

    CIRCLE K®

    Cold
    severe
    congestion

    Acetaminophen, Dextromethorphan HBr, Guaifenesin and Phenylephrine HCl
    Pain Reliever/Fever Reducer, Cough Suppressant, Expectorant, Nasal Decongestant

    ACTUAL SIZE

    Non-Drowsy Relief of
    - Nasal Congestion
    - Sore Throat
    - Cough, Impulse to Cough

    4 Tablets
    2 POUCHES, 2 TABLETS PER POUCH

    PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton
    CIRCLE K COLD 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66715-5728
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide15 mg
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Starch Glycolate Type A Corn (UNII: AG9B65PV6B)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 66715-5728-22 in 1 CARTON12/31/2018
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC: 66715-5728-33 in 1 CARTON10/15/2019
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34111/01/2014
    Labeler - Lil' Drug Store Products, Inc (093103646)

    Revised: 9/2019
     
    Lil' Drug Store Products, Inc


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