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Night Time Severe Cold and Cough Relief

Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 15mL, DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-154

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

Active ingredients
(in each tablespoonful 15 mL)

Acetaminophen 325 mg
Diphenhydramine HCL  12.5 mg
Phenylephrine HCL 5mg


Purpose

Pain reliever/Fever reducer
Cough suppressant/Antihistamine
Nasal decongestant

Keep out of reach of children

Keep out of reach of children

Uses

temporarily relieves these common cold and flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • nasal and sinus congestion
  • runny nose
  • sneezing
  • itchy watery eyes
  • itchy nose or throat
  • cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily reduces fever


Warnings

Liver warnings: This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 6 dose in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Warnings

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 taking  a prescription monamine 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
  • with any other drug containing diphenhydramine, even one used on the skin
  • for children under 4 years of age

Ask a doctor before use if you have
  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or empysema
  • cough that occurs with too much phlegm (mucus)

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

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

Stop use and ask a doctor if
  • nervousness, dizziness or sleeplessness occur
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast feeding

ask a health professional before use.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact the 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

Age                                                                                  Dose

Children under 4 years                                                      Do not use

Children 4 to under 12 years of age                                    Do not use unless directed by a doctor

Adults and children 12 years and over                                2 tablespoonful (30 mL) every 4 hours

  • take only as recommended (see Overdose warning)
  • use dose cup or tablespoon (TBSP)
  • do not take more than 6 doses in any 24-hour period

Other information
  • each tablespoon (15 mL) contains:  potassium 9 mg, sodium 6 mg
  • dosage cup provided
  • store between 20°-25° C (68°-7°7 F)
  • do not refrigerate

Inactive ingredients

Acesulfame potassium, anhydrous citric acid, edetate disodium, FD and C Blue #1, FD and C Red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Product Label

NDC 6801-154-08

*COMPARE TO THE ACTIVE INGREDIENTS IN THERAFUL® WARMING RELIEF COLD AND CHEST CONGESTION

Premier Value®

Night Time Severe Cold and Cough Relief

Acetaminophen ............ Pain Reliever/Fever Reducer
Diphenhydramine.......... Antihistamine/Cough Suppressant
Phenylephrine HCL ...... Nasal Congestion

    Fever and Body Aches
    Sore Throat
    Headache
    Nasal Congestion
    Runny Nose
    Cough

   Cherry Flavor

8.3 FL OZ (245 mL)

PV  Independently Tested Satisfaction Guaranteed

LF-007

DO NOT USE IF PRINTED SEAL UNDER AP IS TORN OR MISSING
Failure to follow these warnings could result in consequences

LB-007

DISTRIBUTED BY CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD SUITE 101
BOCA RATON, FL 33431

Lot:
Exp:

*This product is not manufactured or distributed b Novartis Consumer health Inc., owner of the registered trademark Theraflu® Night Time







NIGHT TIME SEVERE COLD AND COUGH RELIEF 
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-154
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (CHERRY FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-154-08245 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/04/2013
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIOperations
AptaPharma Inc.790523323manufacture(68016-154)

Revised: 12/2014
 
Chain Drug Consortium, LLC

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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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