FDA.reportPublic FDA data

Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl

Manufacturer
OPMX LLC | MEDGEL PRIVATE LIMITED
Effective date
2023-09-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:56:04

Label at a glance#

ProductAcetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE
Label structure8 sections

Indications and uses

Temporarily relieves these symptoms of hay fever or other respiratory allergies: Headache Nasal congestion Sinus congestion & pressure Runny nose and sneezing Minor aches & pain Temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes helps clear nasal passages helps decongest sinus opening and passages

Dosage and administration

Do not take more than directed - See overdose warning Swallow whole; do not crush, chew or dissolve Do not exceed 6 tablets per 24 hours Adults and children 12 years of age & over 1 tablet with water every 4-6 hours as needed Children 4 to 12 years of age Ask a doctor Children under 4 years of age Do not use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg

Chlorpheniramine Maleate 4mg

Phenylephrine HCl 10mg

Purpose

OTC - PURPOSE SECTION

Active Ingredients (in each caplet)Purpose
Acetaminophen 500 mgPain reliever
Chlorpheniramine Maleate 4 mgAntihistamine
Phenylephrine HCl 10 mgNasal descongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms of hay fever or other respiratory allergies:

  • Headache
  • Nasal congestion
  • Sinus congestion & pressure
  • Runny nose and sneezing
  • Minor aches & pain

Temporarily relieves these additional symptoms of hay fever:

  • itching of the nose or throat
  • itchy, watery eyes
  • helps clear nasal passages
  • helps decongest sinus opening and passages

Warnings

WARNINGS SECTION

Liver warning:

SPL UNCLASSIFIED SECTION

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

  • more than 6 tablets in 24 hours, which is the maximum daily amount for this product
  • with other drugs contains acetaminophen
  • 3 or more alcoholic drinks every day while using this product.

Allergy alert:

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:

SPL UNCLASSIFIED SECTION

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

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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, 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
  • to make a child sleepy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

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

  • do not use more than directed
  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or last more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning:

OVERDOSAGE SECTION

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Do not take more than directed - See overdose warning
  • Swallow whole; do not crush, chew or dissolve
  • Do not exceed 6 tablets per 24 hours
Adults and children 12 years of age & over1 tablet with water every 4-6 hours as needed
Children 4 to 12 years of ageAsk a doctor
Children under 4 years of ageDo not use

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature between 20-25°C (68-77ºF)
  • Avoid excessive heat and humidity
  • Tamper Evident: do not use if package or blister unit is open or shows any sing of tampering

Inactive ingredients

INACTIVE INGREDIENT SECTION

magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc

Questions or comments?

OTC - QUESTIONS SECTION

Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or www.opmx.us

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

272737373838

Penimixcina W6Penimixcina W6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2463332acetaminophen 500 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral TabletPSN3
2463332acetaminophen 500 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD3
2463332APAP 500 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-222-062025-01-30C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-272025-01-30C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-372025-01-30C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-382025-01-30C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-272023-09-04C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-372023-09-04C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-382023-09-04C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-272022-01-28C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-372022-01-28C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-222-382022-01-28C16284748780-1d6a99b39-b33c-a426-e053-dadaa90af4c2Pentrexcilina - Daytime (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-222-06Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl2 in 1 POUCHTABLET23
69729-222-06Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl3 in 1 CARTONTABLET33
69729-222-27Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl2 in 1 POUCHTABLET23
69729-222-37Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl12 in 1 POUCHTABLET123
69729-222-38Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl144 in 1 POUCHTABLET1443

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-222ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL TABLET [OPMX LLC]3Legacy NDC, 5 package rows20230905_b3c2158c-6ee1-dba9-e053-2995a90a8555.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-22269729-222-27, 69729-222-37, 69729-222-38, 69729-222-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
TALC7SEV7J4R1UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
POVIDONE K30U725QWY32XIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ACETAMINOPHEN362O9ITL9DACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB

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
048e2463-1588-38a4-e063-6394a90a06d5b3c2158c-6ee1-dba9-e053-2995a90a85552023-09-04WarningsExact identifier
spl id: 048e2463-1588-38a4-e063-6394a90a06d5
spl set id: b3c2158c-6ee1-dba9-e053-2995a90a8555

Reported adverse events (FAERS/openFDA)#

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