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COLD and FLU Day Time Multi-Symptom Relief

Medically reviewed on May 9, 2018

Dosage form: solution
Ingredients: ACETAMINOPHEN 325mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-706

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.

Drug Facts

Active ingredients (in each 15 mL tablespoon)                      Purpose


Acetaminophen, USP 325 mg …………………......…………Pain reliever/fever reducer

Dextromethorphan HBr, USP 10 mg ………….......………….Cough suppressant

Phenylephrine HCl, USP 5 mg …………………............……..Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever

Warnings

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

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product.

Allergy alert: acetaminophen may cause severe skin reactions.

 Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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.

Ask a doctor before use if you have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • a sodium-restricted diet

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

When using this product, do not use more than directed

Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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.

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 (1-800-222-1222). Prompt medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions
  • take only as directed – see Overdose warning
  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses (60 mL) (4 TBSP) per 24 hours
  • mL = milliliter; TBSP = tablespoon
adults & children 12 years & over
30 mL (2 TBSP) every 4 hours
children 6 to under 12 years
15 mL (1 TBSP) every 4 hours
children 4 to under 6 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

Other information
  • each 15 mL contains: sodium 49 mg
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose  sodium, edetate disodium, FD&C Yellow no. 6, flavor, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

Questions or Comments?

1-855-274-4122

Distributed by:
Pharmacy Value Alliance LLC
407 East Lancaster Avenue,
Wayne, PA 19087
www.emersongroup.com
MADE IN USA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)

Compare to the active ingredients
in Vicks® DayQuil® COLD & FLU
Multi-Symptom Relief*

Premier Value®

Cold & Flu
Day Time
Multi-Symptom Relief

325 mg - Acetaminophen USP (Pain Reliever/Fever Reducer)
5 mg - Phenylephrine HCl USP (Nasal Decongestant)
10 mg - Dextromethorphan HBr USP (Cough Suppressant)


  • Aches, Fever & Sore Throat
  • Nasal Congestion
  • Cough

Non-Drowsy
Alcohol Free/Antihistamine Free

8 FL OZ (237 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

Compare to the active ingredients
in Vicks® DayQuil® COLD & FLU
Multi-Symptom Relief*

Premier Value®

Cold & Flu
Day Time
Multi-Symptom Relief

325 mg - Acetaminophen USP (Pain Reliever/Fever Reducer)
5 mg - Phenylephrine HCl USP (Nasal Decongestant)
10 mg - Dextromethorphan HBr USP (Cough Suppressant)


  • Aches, Fever & Sore Throat
  • Nasal Congestion
  • Cough

Non-Drowsy                     
Alcohol Free/Antihistamine Free

12 FL OZ (354 mL)
 

COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF 
acetaminophen, phenylephrine hcl, and dextromethorphan hbr solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-706
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
CARBOXYMETHYLCELLULOSE SODIUM 
EDETATE DISODIUM 
FD&C YELLOW NO. 6 
ORANGE 
GLYCERIN 
MENTHOL, UNSPECIFIED FORM 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM ANHYDROUS 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColorORANGE (Orange to Reddish Brown) Score    
ShapeSize
FlavorAPRICOT, ORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-706-08237 mL in 1 BOTTLE
2NDC:68016-706-12354 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/27/2015
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(68016-706)

 
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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