The following Structured Product Label (SPL) was submitted to the FDA by A P J Laboratories Limited for the product Daytime Nighttime Cold/flu Relief (NDC 46084-121). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
PART 1 OF 2 DAYTIME COLD AND FLU RELIEF
Acetaminophen 325 mg
Dextromethorphan Hydrobromide 10 mg
Phenylephrine HCl 5 mg
PART 2 OF 2 NIGHTTIME COLD AND FLU RELIEF
Acetaminophen 325 mg
Dextromethorphan Hydrobromide 10 mg
Chlorpheniramine Maleate 6.25 mg
Purpose for Daytime
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Purpose for Nighttime
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.
Temporarily relieves common cold/flu symptoms:
•cough due to minor throat and bronchial irritation
•sore throat
•headache
•minor aches and pains
•fever
•runny nose and sneezing (Nighttime only)
•nasal congestion (Daytime only)
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take
•more than 4 doses in 24 hours, which is the maximum daily amount for these products
•with other drugs containing acetaminophen
•3 or more alcoholic drinks every day while using these products
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
•to make a child sleep (Nighttime only)
•take only as directed – see Overdose warning
•take Nighttime OR Daytime.
Nighttime tablets
•do not exceed 4 doses per 24 hours
adults and children 12 years and over swallow 2 softgels with water every 6 hrs
children 4 to under 12 years ask a doctor
children under 4 years do not use
DayTime tablets
•do not exceed 4 doses per 24 hours
adults and children 12 years and over swallow 2 softgels with water every 4 hrs
children 4 to under 12 years ask a doctor
children under 4 years do not use
•when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
STARCH, CORN
BUTYLATED HYDROXYTOLUENE
METHYLPARABEN
PROPYLPARABEN
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
MAGNESIUM STEARATE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
SODIUM LAURYL SULFATE
ISOPROPYL ALCOHOL
METHYLENE CHLORIDE
FD and C YELLOW NO. 6
HYPROMELLOSES
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