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

CounterAct

Melaleuca, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
CounterAct Night Content of Label



FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients (in each caplet)
Acetaminophen 325 mg
Diphenhydramine HCI 25 mg
Phenylephrine HCI 5 mg

Purpose

Purpose
Pain reliever/fever reducer
Antihistamine
Nasal decongestant

Uses

Uses

  • temporarily relieves these symptoms of hay fever and the common cold:
    • runny nose
    • nasal congestion
    • headache
    • sinus pressure and congestion
    • sore throat
    • minor aches and pains
    • sneezing
  • temporarily relieves these additional symptoms of hay fever:
    • itching of the nose or throat
    • itchy, watery eyes
  • 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.
  • with any other product containing diphenhydramine, even one used on skin
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, phychiatric 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • heart disease
  • liver disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or  chronic bronchitis

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion 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

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 use more than directed (see overdose warning) adults and children 12 years and over
    • take 2 caplets every 4 hours
    • 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 temperature 15°-30°C (59°-86°F)

Inactive ingredients  corscarmellose sodium, crospovidone, FD and C No. 1, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Questions or comments?  1-800-282-3000

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

CounterAct

Acetaminophen, Diphenydramine HCI, Phenylephrine HCI TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54473-184
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FD&C BLUE NO. 1
hydroxypropyl cellulose
HYPROMELLOSES
MAGNESIUM STEARATE
polyethylene glycol
povidone
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
blue (Blue) 18 mm GPI;A5 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 36 in 1 BLISTER PACK
2 NDC:54473-184-36 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-08-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.