Your browser does not support JavaScript! DAY TIME COLD MULTI-SYMPTOM (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]
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DAY TIME COLD MULTI-SYMPTOM (acetaminophen, phenylephrine hcl and dextromethorphan hbr) capsule, liquid filled
[DOLGENCORP, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredients (in each gelcap)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

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

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.

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 

Other information

  • store at controlled room temperature 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, 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

Questions?

1-888-309-9030

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

DAY TIME COLD MULTI-SYMPTOM 
acetaminophen, phenylephrine hcl and dextromethorphan hbr capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55910-560
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code L;0
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-560-081 in 1 CARTON
124 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34303/29/2008
Labeler - DOLGENCORP, LLC (068331990)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(55910-560)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(55910-560)

Revised: 11/2012
 
DOLGENCORP, LLC

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