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Cold and Chest Congestion Relief

Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 15mL, GUAIFENESIN 200mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-299

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 tablespoon 15 mL)

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCL 5 mg

Purpose

Pain reliever/Fever reducer
Expectorant
Nasal Decongestant


Keep out of reach of children.

Keep out of reach of children.

Uses

temporarily relieves

  • minor aches and pains
  • sore throat
  • headache
  • nasal and sinus congestion
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive

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
  • 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.

When using this product
  • do not use more than directed

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: sodium 10 mg, potassium
  • 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 Yellow #6, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate


Questions?

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

Product Label

NDC 6801-299-08

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

Premier Value®

Cold and Chest Congestion Relief

Acetaminophen ............ Pain Reliver/Fever Reducer
Guaifensin ................... Expectorant
Phenylephrine HCL ...... Nasal Congestion

    Thins and Loosens Mucus
    Nasal and Chest Congestion
    Sore Throat
    Body Ache
    Headache
    Fever

Orange Flavor Liquid

8.3 FL OZ (245 mL)

PV  Independently Tested Satisfaction Guaranteed

LF-005

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

LB-005

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® Cold and Chest Congestion




COLD AND CHEST CONGESTION RELIEF 
acetaminophen, guaifenesin , phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-299
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 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 YELLOW NO. 6 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE (ORANGE) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-299-08245 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/18/2014
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIOperations
AptaPharma Inc.790523323manufacture(68016-299)

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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