CounterAct description, usages, side effects, indications, overdosage, supplying and lots more!

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CounterAct

Melaleuca, Inc.

CounterAct Day Content of Label




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients (in each caplet)

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

Purpose

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

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:

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.

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

CounterActCounterAct

CounterAct

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54473-185
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Guaifenesin GUAIFENESIN 200 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
yellow (Yellow) 19 mm G14 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:54473-185-36 3 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-10-01


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Be sure to consult your doctor before taking any medication!
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