Antiflu Des

Manufacturer
Productos Farmaceuticos, S.A. de C.V.
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:27:17

Label at a glance#

ProductAntiflu Des Cough and Flu
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE
Label structure15 sections

Indications and uses

Temporarily relieves common cold and flu symptoms: ▪sore throat ▪headache ▪minor aches and pains ▪fever ▪stuffy/runny nose and sneezing

Dosage and administration

▪ Do not take more than recommended dose Adults and children 12 years of age and over: take 1 capsule with water every 4 hours. ▪ Do not exceed 6 capsules in 24 hours Children under 12 years of age: do not use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Phenylephrine HCl 10 mg

Chlorpheniramine Maleate 4 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Nasal decongestant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold and flu symptoms: ▪sore throat ▪headache ▪minor aches and pains ▪fever ▪stuffy/runny nose and sneezing

Warnings

WARNINGS SECTION

Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ▪More than 4,000 mg 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.

Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms can include▪ skin reddening ▪ blisters ▪ rash ▪ hives ▪ facial swelling ▪ asthma (wheezing) ▪ shock. If a skin or any allergic reaction occurs, stop use and seek medical attention right away.

Sore throat warning: Severe or persistent sore throat lasting more than 2 days or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a 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. If you are now taking a prescription Monoamine Oxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or if you have taken these products 2 weeks previously. If you do not know if your prescription drug contains an MAOI, ask a Doctor before taking this product

Ask a Doctor before use if you have

OTC - ASK DOCTOR SECTION

▪ Liver disease ▪ Heart disease ▪ High blood pressure ▪ Thyroid disease ▪ Diabetes ▪Glaucoma ▪ Breathing problem due to any given cause (asthma, chronic bronchitis or emphysema) ▪ Trouble urinating due to an enlarged prostate gland

Ask a Doctor before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

▪Taking sedatives or tranquilizers ▪Taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

▪ Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a Doctor. ▪ Do not mix with alcohol, sedatives and tranquilizers as they may increase drowsiness ▪ Driving a motor vehicle or operating machinery could be affected ▪ Excitability may occur especially in children(12-18 y) ▪ if symptoms do not improve within 7 days or are accompanied by fever, consult a Doctor

Stop use and ask a Doctor if

OTC - STOP USE SECTION

▪ Pain, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) ▪ Fever gets worse or last more than 3 days ▪ Redness or swelling is present ▪ New symptoms occur

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

As with all medical products keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 recommended dose Adults and children 12 years of age and over: take 1 capsule with water every 4 hours. ▪ Do not exceed 6 capsules in 24 hours Children under 12 years of age: do not use

Other information

SPL UNCLASSIFIED SECTION

Do not store above 77ºF(25ºC) and in a dry place

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Colloidal Silcon Dioxide, D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, FD&C Blue No. 1, Gelatin, Lactose Monohdyrate, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Shellac, Synthetic Iron Oxide, Titanium Dioxide

Questions and Comments?

SPL UNCLASSIFIED SECTION

You may report any side effects to 1-305-677-0850 Monday through Sunday 24 hrs

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2599517acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral CapsulePSN2
2599517acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral CapsuleSCD2
2599517APAP 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral CapsuleSY2

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
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82688-001-12Antiflu DesCough and Flu1 in 1 CARTONCAPSULE12
82688-001-12Antiflu DesCough and Flu12 in 1 BLISTER PACKCAPSULE122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82688-001ANTIFLU DES COUGH AND FLU (ACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATE) CAPSULE [PRODUCTOS FARMACEUTICOS, S.A. DE C.V.]2Current NDC, Legacy NDC, 2 package rows20241019_dcf3897a-a793-6df7-e053-2995a90a25f8.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82688-00182688-001-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
Antiflu Des Cough and FluACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATEProductos Farmaceuticos, S.A. de C.V.dcf3897a-a793-6df7-e053-2995a90a25f82024-10-17WarningsExact identifier
ndc (package): 82688-001-12
ndc (product): 82688-001
ndc11 (package): 82688000112
spl id: 24b33596-d38f-be47-e063-6394a90ab641
spl set id: dcf3897a-a793-6df7-e053-2995a90a25f8

Reported adverse events (FAERS/openFDA)#

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