CounterAct

Manufacturer
Melaleuca, Inc.
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:54:46

Label at a glance#

ProductCounterAct Night
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure19 sections

Boxed warning

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

Storage and handling

Other information store at controlled temperature 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose
Pain reliever/fever reducer
Antihistamine
Nasal decongestant

INDICATIONS & USAGE SECTION

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 SECTION

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: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Other information

  • store at controlled temperature 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments?  1-800-282-3000

BOXED WARNING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of blister
image of blister

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of box
image of box

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD401
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
CROSPOVIDONEINACTIVE INGREDIENT68401960MK1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671P1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1A1
POVIDONEINACTIVE INGREDIENTFZ989GH94E1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-18454473-184-01, 54473-184-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 347 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii candidate
37 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, FILM COATED, EXTENDED RELEASE / ORAL187.6 mgExact identifier — unii candidate
27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1576 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJDROPS / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, ORALLY DISINTEGRATING / ORAL4 mgExact identifier — unii candidate
27 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL21 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION/ DROPS / OPHTHALMIC3 mgExact identifier — unii candidate
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSOAP / TOPICAL1 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESOLUTION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
30 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PSOLUTION / TOPICAL200 mgExact identifier — unii candidate
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED, EXTENDED RELEASE / ORAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii candidate
37 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, DELAYED RELEASE / ORAL105 mgExact identifier — unii candidate
27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPELLET / ORAL1140 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PPOWDER, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48POWDER, FOR SUSPENSION / ORAL11.25 mgExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED / ORAL17 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SOLUTION / ORAL690 mgExact identifier — unii candidate
28 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / TOPICAL8 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, EXTENDED RELEASE / ORAL168 mgExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
49 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, COATED PELLETS / ORAL198 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PGRANULE, FOR SUSPENSION / ORAL194 mgExact identifier — unii candidate
27 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJINSERT / VAGINAL147 mgExact identifier — unii candidate
22 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / NASAL20 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOJELLY / TOPICALNAExact identifier — unii candidate
27 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APIMPLANT / SUBCUTANEOUS1.04 mgExact identifier — unii candidate
26 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, EXTENDED RELEASE / ORAL119.7 mgExact identifier — unii candidate
27 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETROCHE / ORAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PFILM / BUCCAL87 mgExact identifier — unii candidate
27 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
26 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PCAPSULE, COATED PELLETS / ORAL41.4 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSEHYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PGEL / TRANSDERMAL20 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSYRUP / ORAL250 mgExact identifier — unii candidate
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48SUSPENSION / ORAL150 mgExact identifier — unii candidate
22 equally ranked IID candidates

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
994f4954-8668-606b-e053-2a95a90a5c50c500f07b-1a07-4afb-a98c-4a8ee9e166752019-12-09Boxed warning, WarningsExact identifier
spl id: 994f4954-8668-606b-e053-2a95a90a5c50
spl set id: c500f07b-1a07-4afb-a98c-4a8ee9e16675

Reported adverse events (FAERS/openFDA)#

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