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CounterAct PM

Medically reviewed on November 15, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Melaleuca, Inc.
NDC Code: 54473-182

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.

Melaleuca CounterAct PM

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg
Diphenhydramine HCI 25 mg

Purpose

Pain reliever
Nighttime sleep aid

Usestemporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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
  • in children under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • trouble urinating due to enlargement of the 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

  • drowsiness will occur
  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

  • sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

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(1-800-222-1222). 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 of age and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product 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)
  • see end flap for expiration date and lot number

Inactive ingredientscroscarmellose sodium, crospovidone, FD and C Blue #1, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, silica, sodium starch glycolate, stearic acid and titanium dioxide

Questions or comments?If you have any questions or comments or to report an adverse event, please contact 1-800-282-3000.

Dist. by: Melaleuca, Inc.

Idaho Falls, ID 83402-6003

To order: 1-800-282-3000

www.melaleuca.com

Do not use if carton is open, or if imprinted safety seal under cap is broken or missing.

Melaleuca

EXTRA-STRENGTH

CounterAct®PM

Pain Reliever & Sleep Aid

Acetaminophen 500mg

with Diphenhydramine HCl 25mg

For Pain with Sleeplessness

See New Warnings Information

50 Caplets

COUNTERACT  PM
acetaminophen and diphenhydramine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-182
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
FD&C BLUE NO. 1 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
STARCH, CORN 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
Colorblue (Blue) Scoreno score
ShapeCAPSULE (Caplet) Size18mm
FlavorImprint CodeGP325
Contains    
Packaging
#Item CodePackage Description
1NDC:54473-182-501 BOTTLE in 1 BOX
150 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/01/2011
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIOperations
Gemini Pharmaceuticals, Inc.055942270manufacture(54473-182)

 
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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