Label: DAY TIME COLD MULTI-SYMPTOM- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/12

If you are a consumer or patient please visit this version.

  • Active ingredients (in each gelcap)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCl 5 mg

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  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant

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  • Uses

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

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 12 gelcaps 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

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

    Ask a doctor before use if

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

    Ask a doctor or pharmacist before use if

    • 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
    • cough comes back or occurs with rash or headache that lasts

    These could be sgins of a serious condition. 

    If pregnant or breast-feeding,

     ask a health professional before use.

    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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    • do not take more than directed (see overdose warning)
    • adults and children 12 years and over
    • take 2 gelcaps every 4 hours
    • do not take more than 12 gelcaps in 23 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 
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  • Other information

    • store at controlled room temperature 15º-30ºC (59º-86ºF) 
    • see end flap for expiration date and lot number
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  • Inactive ingredients

     croscarmellose sodium, crospovidone, D&C red #28, FD&C blue #1, FD&C red #40, 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, sillica gel, stearic acid, titanium dioxide

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  • Questions?

    1-888-309-9030

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  • Principal Display Panel

    DG
    health

    Compare to active ingredients in Tylenol® Cold Multi-Symptom Daytime*

    Day Time
    Cold
    Multi-Symptom
    Pain Reliever/Fever Reducer,
    Nasal Decongestant, Cough Suppressant

    Fever, Headache, Sore Throat • Acetaminophen
    Nasal Congestion • Phenylephrine HCl
    Coughing • Dextromethorphan HBr

    SEE NEW WARNINGS INFORMATION

    Pseudoephedrine Free

    24 Gelcacps
    Non-Drowsy

    Rapid Release

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by McNeil Consumer Healthcare., owner of the registered trademark Tylenol® Cold Mutli-Symptom Daytime.
    50844   ORG100956008

    DISTRIBUTED BY DOLGENCORP, LLC
    100 MISSIONS RIDGE
    GOODLETTSVILLE, TN 37072

    Dollar General 44-560

    Dollar General 44-560

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  • INGREDIENTS AND APPEARANCE
    DAY TIME COLD MULTI-SYMPTOM 
    acetaminophen, phenylephrine hcl and dextromethorphan hbr capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55910-560
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    CROSPOVIDONE  
    D&C RED NO. 28  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    HYDROXYPROPYL CELLULOSE (TYPE H)  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOLS  
    POVIDONES  
    PROPYLENE GLYCOL  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color RED Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code L;0
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55910-560-08 1 in 1 CARTON
    1 24 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 03/29/2008
    Labeler - DOLGENCORP, LLC (068331990)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(55910-560)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(55910-560)
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