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Severe cold and cough relief

Medically reviewed on Dec 15, 2017

Dosage form: liquid
Ingredients: ACETAMINOPHEN 650mg in 30mL, DEXTROMETHORPHAN HYDROBROMIDE 20mg in 30mL, PHENYLEPHRINE HYDROCHLORIDE 10 mg in 30mL
Labeler: AAFES/Your Military Exchanges
NDC Code: 55301-316

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 30 mL)

Acetaminophen 650 mg

Dextromethoprhan HBr 20 mg

Phenlyephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses
  • temporarily relieves these symptoms due to a cold
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever

Warnings

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

  • more than 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allery 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, 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 non-prescription). 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 the user has
  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • 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
  • nervousness, dizziness or sleeplessness occurs 
  • pain, nasal congestion 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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not take more than directed (see overdose warning)
  • do not exceed 6 doses in any 24 hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL=milliliter
  • keep dosing cup with product
  • adults and children 12 years and over: 30 mL every 4 hours
  • children under 12 years of age: do not use

Other information
  • each 30 mL contains: sodium 16 mg
  • store between 20-25ºC (68-77ºF)
  • do not refrigerate

Inactive ingredients

acesulfame potassium, alcohol, citric acid, disodium EDTA, FD&C Blue# 1, FD&C Red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate.

Questions or comments?

Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Compare to the active ingredients in Theraflu® Daytime Severe cold & cough*

Severe cold and cough relief

Daytime

Acetaminophen 650 mg/ Pain reliever/ fever reducer

Dextromethorphan HBr 20 mg/ Cough Suppressant

Phenylephrine HCl 10 mg/ Nasal Decongestant

cough

nasal congestion

aches, fever & sore throat

Manufactured for your Military Exchanges

By: PL Developments, 11865 S. Alameda st., Lynwood, CA 90262

8.3 fl oz (245 mL)

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Theraflu® Daytime severe cold and cough

Package Label

Severe cold and cough relief

SEVERE COLD AND COUGH RELIEF 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-316
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10  mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ALCOHOL 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE, UNSPECIFIED FORM 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55301-316-08245 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/16/2015
Labeler - AAFES/Your Military Exchanges (001695568)
Registrant - P & L Development, LLC (800014821)

 
AAFES/Your Military Exchanges

Further information

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

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