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Daytime and Nighttime Cold and Flu Relief Plus

Medically reviewed on October 13, 2017

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, DOXYLAMINE SUCCINATE 6.25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-721

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.

Multi-Symptom Daytime and Nighttime Cold and Flu Relief Plus

Drug Facts

Active ingredients (in each capsule) for DAY TIME

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Active ingredients (in each capsule) for NIGHT TIME

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

Purposes (DAY TIME)

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purposes (NIGHT TIME)

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses (DAY TIME)
  • temporarily relieves these symptoms due to a cold or flu:

  • minor aches and pains

  • headache

  • cough

  • sore throat

  • nasal and sinus congestion

  • temporarily reduces fever

Uses (NIGHT TIME)
  • temporarily relieves these symptoms due to a cold or flu:

  • minor aches and pains

  • headache

  • nasal and sinus congestion

  • cough

  • sore throat

  • runny nose

  • sneezing

  • temporarily reduces fever

Warnings (DAY TIME)

Liver warnings: This product contains acetaminophen.

Sever liver damage may occur if you take

  • more than 10 capsules in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

If a skin or general allergic 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.

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.

  • if you have ever had an allergic reaction to this product or any of its ingredients

  • in children under 12 years of age

Ask a doctor before use if you have
  • liver disease

  • heart disease

  • high blood pressure

  • thyroid disease

  • diabetes

  • cough with excessive phlegm (mucus)

  • difficulty in urination due to enlargement of the prostate gland

  • persistent or chronic cough such as occurs with smoking, asthma, 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, cough, or nasal congestion gets worse or lasts more than 7 dayspain, cough, or nasal congestion 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.

  • nervousness, dizziness, or sleeplessness occurs

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

Warnings (NIGHT TIME)

Liver warnings: This product contains acetaminophen.

Sever liver damage may occur if you take

  • more than 10 capsules in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

If a skin or general allergic 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.

Do not use to sedate children.

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.

  • if you have ever had an allergic reaction to this product or any of its ingredients

  • in children under 12 years of age

Ask a doctor before use if you have
  • liver disease

  • heart disease

  • high blood pressure

  • thyroid disease

  • diabetes

  • glaucoma

  • cough with excessive phlegm (mucus)

  • a breathing problem such as emphysema or chronic bronchitis

  • difficulty in urination due to enlargement of the prostate gland

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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

  • taking sedatives or tranquilizers

When using this product
  • do not exceed recommended dosage

  • may cause marked drowsiness

  • avoid alcoholic drinks

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • be careful when driving a motor vehicle or operating machinery

  • excitability may occur, especially in children

Stop use and ask a doctor if
  • pain, cough, or nasal congestion gets worse or lasts more than 7 dayspain, cough, or nasal congestion 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.

  • nervousness, dizziness, or sleeplessness occurs

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

Directions (DAY TIME and NIGHT TIME)
  • do not take more than the recommended dose

  • adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.

  • children under 12 years: do not use

Other information (DAY TIME and NIGHT TIME)
  • store at controlled room temperature 15°C to 30°C (59°F to 86°F)

  • do not use if blister seal is ripped or broken

Inactive ingredients (DAY TIME

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerine, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white ink

Inactive ingredients (NIGHT TIME)

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

Questions or comments? (DAY TIME and NIGHT TIME)

1-800-706-5575

*This product is not manufactured or distributed by Bayer HealthCare LLc., distributor of Alka-Seltzer PLUS®.

Principal Display Panel

MULTI-SYMPTOM NON-DROWSY - DAY TIME

Cold & Flu Relief Plus

NDC number 68016-721-20

12 Liquid Gels 


MULTI-SYMPTOM NON-DROWSY - NIGHT TIME

Cold & Flu Relief Plus

NDC number 68016-721-20

8 Liquid Gels

DAYTIME AND NIGHTTIME COLD AND FLU RELIEF PLUS 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-721
Packaging
#Item CodePackage Description
1NDC:68016-721-201 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 12 
Part 21 BLISTER PACK
Part 1 of 2
DAYTIME COLD AND FLU RELIEF PLUS 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
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
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code95A
Contains    
Packaging
#Item CodePackage Description
18 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/17/2015
Part 2 of 2
NIGHTTIME COLD AND FLU RELIEF PLUS 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate capsule, liquid filled
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN ) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code94A
Contains    
Packaging
#Item CodePackage Description
18 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/17/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/17/2015
Labeler - Chain Drug Consortium, LLC (101668460)
Establishment
NameAddressID/FEIOperations
Accucaps Industries Limited248441727analysis(68016-721), manufacture(68016-721)
Establishment
NameAddressID/FEIOperations
Accucaps Industries Limited Strathroy243944050analysis(68016-721), manufacture(68016-721)
Establishment
NameAddressID/FEIOperations
Legacy Pharmaceutical Packaging969852743pack(68016-721)

 
Chain Drug Consortium, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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