CounterAct

Manufacturer
Melaleuca, Inc. | Advance Pharmaceutical
Effective date
2019-01-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:16

Label at a glance#

ProductCounterAct PM
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure15 sections

Indications and uses

temporary relief of occassional headaches, minor aches, and pains with accompanying sleeplessness

Dosage and administration

do not take more than directed (see overdose warning) adults and children 12 years 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.

Storage and handling

store at controlled room temperature 15-30 o C (59-86 o F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Do Not Use

OTC - DO NOT USE SECTION

  • 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 are allergic to acetaminophen or any of the ingredients in this product

Warnings

WARNINGS SECTION

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

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

These could be signs of a serious condition

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Purpose

OTC - PURPOSE SECTION

Pain reliever

Nighttime sleep-aid

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed (see overdose warning)
adults and children 12 years 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.

Other Information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 15-30 oC (59-86 oF)
  • see end flap for expiration date and lot number

Questions or comments?

OTC - QUESTIONS SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, corn starch, citric acid, croscarmellose sodium, hypromellose, lactose, magnesium silicate,

magnesium stearate, maltodextrin, microcrystalline cellulose, medium-chain triglyceride, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium carbonate, sodium starch glycolate, stearic acid.

Do not take this product unless directed by a doctor if you have

OTC - DO NOT USE SECTION

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis

Uses

INDICATIONS & USAGE SECTION

temporary relief of occassional headaches, minor aches, and pains with accompanying sleeplessness

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottleBoxBox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD2
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-304-01CounterActPM1 in 1 BOXTABLET12
54473-304-50CounterActPM50 in 1 BOTTLETABLET502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-304COUNTERACT PM (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET [MELALEUCA, INC.]2Current NDC, Legacy NDC, 2 package rows20190119_7f9a0062-0e86-1deb-e053-2a91aa0a9188.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-30454473-304-50, 54473-304-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CounterAct PMACETAMINOPHEN AND DIPHENHYDRAMINEMelaleuca, Inc.7f9a0062-0e86-1deb-e053-2a91aa0a91882019-01-18WarningsExact identifier
ndc (package): 54473-304-01
ndc (package): 54473-304-50
ndc (product): 54473-304
ndc11 (package): 54473030401
ndc11 (package): 54473030450
spl id: 7fbf2b51-9097-0a1f-e053-2991aa0a6aa1
spl set id: 7f9a0062-0e86-1deb-e053-2a91aa0a9188

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.