COUNTERACT PM - acetaminophen and diphenhydramine hydrochloride tablet, film coated 
Melaleuca, Inc.

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.

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Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCI 25 mg

Purpose
Pain reliever
Nighttime sleep-aid

Use  temporary 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:

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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

Other information

Inactive ingredients  colloidal silicon dioxide, corn starch, croscarmellose sodium, FD and C blue No. 1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

image of label

image of box

Questions or comments?  1-800-282-3000

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


COUNTERACT  PM
acetaminophen and diphenhydramine hci tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-138
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
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
POLYETHYLENE GLYCOL 
POLYVINYL ALCOHOL 
POVIDONE 
SILICON DIOXIDE 
STARCH, CORN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
Colorblue (Blue) Score no score
ShapeCAPSULE (Capsule shaped) Size18mm
FlavorImprint Code 44;235
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:54473-138-501 BOTTLE ( BOTTLE) in 1 BOXcontains a BOTTLE
150 TABLET, FILM COATED ( TABLET) in 1 BOTTLEThis package is contained within the BOX (54473-138-50)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34309/15/201003/31/2011

Labeler - Melaleuca, Inc. (139760102)

Revised: 03/2011 Melaleuca, Inc.