CounterAct Day

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Melaleuca, Inc.
NDC Code: 54473-185

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.

CounterAct Day Content of Label

Active ingredients (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCI 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

  • temporarily relieves these common cold/flu symptoms:
    • headache
    • minor aches and pains
    • sore throat
    • nasal congestion
    • cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

Warnings

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

  • more than 12 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
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 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
  • diabetes
  • heart disease
  • trouble urinating due to and enlarged prostate gland
  • high blood pressure
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • thyroid disease

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 occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headaches 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 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

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 12 caplets in 24 hours
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

Inactive ingredients  croscarmellose sodium, crospovidone, D and C yellow number 10 lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?  1-800-426-9391

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING

COUNTERACT  DAY
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-185
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
D&C YELLOW NO. 10 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
POVIDONE 
STARCH, CORN 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
Coloryellow (Yellow) Scoreno score
ShapeOVAL (Oval Tablet) Size19mm
FlavorImprint CodeG14
Contains    
Packaging
#Item CodePackage Description
1NDC:54473-185-363 BLISTER PACK (BLISTER PACK) in 1 BOX
112 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2011
Labeler - Melaleuca, Inc. (139760102)

Revised: 08/2011
 
Melaleuca, Inc.

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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