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Nighttime Cold and flu Relief by Chain Drug Consortium, LLC

Medically reviewed on January 31, 2018

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, DOXYLAMINE SUCCINATE 6.25mg
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-599

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.

Premier Value (CDC) Multi-Symptom Nighttime Cold/Flu Relief Drug Facts

Active ingredients (In each capsule)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/Fever reducer

Cough suppressant

Antihistamine

Uses
  • temporarily relieves common cold/flu symptoms:
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing

Warnings

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

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product 
  • with other drugs containing acetaminophen
  • 3 or more alcohol drinks daily while using this product

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

Ask a doctor before use if you have
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives & tranquilizers may increase drowsiness

Stop use and ask doctor if
  • pain 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 occurs with rash or headache that lasts.

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.

Over dose 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 & children even if you do not notice any signs or symptoms.

Directions
  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hours 
    adults & children 12 yrs & over2 capsules with water every 6 hrs
    children 4 to under 12 yrsask a doctor
    children under 4 yrsdo not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information
  • store at controlled room temperature 15°C to 30°C (59°F to 86°F)
  • avoid excessive heat

Inactive ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerine, polyethylene glycol 400, povidone K12, propylene glycol, purified water, sorbitol sorbitan solution, white ink.

Questions or comments?

Call 1-800-706-5575

Principal Display Panel

Premier Value

Multi-Symptom

Nighttime Cold/Flu Relief

NDC number 68016-599-16

16 Softgel

16 Liquid Capsule

NIGHTTIME COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hbr, doxylamine succinate, capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-599
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONE K12 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code94A
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-599-168 CARTON in 1 BLISTER PACK
12 CAPSULE, LIQUID FILLED in 1 CARTON
2NDC:68016-599-2412 CARTON in 1 BLISTER PACK
22 CAPSULE, LIQUID FILLED in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/12/2015
Labeler - Chain Drug Consortium, LLC (101668460)
Establishment
NameAddressID/FEIOperations
Catalent Ontario Limited248441727analysis(68016-599), manufacture(68016-599)
Establishment
NameAddressID/FEIOperations
Catalent Ontario Limited243944050analysis(68016-599), manufacture(68016-599)
Establishment
NameAddressID/FEIOperations
Legacy Pharmaceutical Packaging143213275pack(68016-599)

 
Chain Drug Consortium, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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