Cold Medicine

Manufacturer
Selder, S.A. de C.V.
Effective date
2024-10-24
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:29:51

Label at a glance#

ProductCold Medicine XL3 FORTE
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure15 sections

Indications and uses

temporarily relieves ■ minor aches and pains ■ headaches ■ nasal congestion ■ sinus congestion & pressure ■ runny nose ■sneezing

Dosage and administration

■ Do not use more than directed (see overdose warning) ■ Adults and children 12 years of age and older: take 1 tablet every 4 hours Do not take more than 6 tablets in 24 hours ■ Children under 12 years of age: do not use because this product contains to much medication for children under this age.

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Chlorpheniramine maleate 4 mg
Phenylepherine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Antihistamine
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves ■ minor aches and pains ■ headaches ■ nasal congestion ■ sinus congestion & pressure ■ runny nose ■sneezing

Warnings

WARNINGS SECTION

Liver warning: 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 ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product

Alergy alert 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

Do not use

OTC - DO NOT USE SECTION

■ If you are allergic to acetaminophen ■ more than 10 days unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor ■ if you are taking a 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 contasins an MAOI, ask a doctor or pharmacist before taking this product. ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask adoctor before use if you have

OTC - ASK DOCTOR SECTION

■ liver disease ■ heart disease ■ glaucoma ■ 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

OTC - ASK DOCTOR/PHARMACIST SECTION

■ are taking the blood thinning drug warfarin ■ are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ redness or swelling is present ■ new symptoms occur ■ you get nervous, dizzy, or sleepless ■ pain or nasal congestion gets worse or lasts for more than 7 days ■ fever gets worse or lasts for more than 3 days

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. 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 (1-800-222-1222) 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

DOSAGE & ADMINISTRATION SECTION

■ Do not use more than directed (see overdose warning) ■ Adults and children 12 years of age and older: take 1 tablet every 4 hours Do not take more than 6 tablets in 24 hours ■ Children under 12 years of age: do not use because this product contains to much medication for children under this age.

Other Information

SPL UNCLASSIFIED SECTION

■ store at room temperature 59-86F (15-30C) ■ do not use if package is torn or damaged

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lactose monohydrate (derived from milk), Stearic acid, Povidone, Alcohol, Water purified, Hypromellose, Titanium dioxide, Triacetin, contains FDC Yellow No. 5 (tartrazine) as color additive

Questions and Comments?

OTC - QUESTIONS SECTION

You may report side effects to 1-855-259-1590 Monday through Friday 9AM-5PM EST

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1193293acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral TabletPSN7
1193293acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD7
1193293APAP 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSY7

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
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63654-601-01Cold MedicineXL3 FORTE10 in 1 BLISTER PACKTABLET107
63654-601-02Cold MedicineXL3 FORTE10 in 1 BLISTER PACKTABLET107
63654-601-04Cold MedicineXL3 FORTE4 in 1 PACKETTABLET47
63654-601-10Cold MedicineXL3 FORTE1 in 1 BOXTABLET17
63654-601-20Cold MedicineXL3 FORTE2 in 1 BOXTABLET27
63654-601-50Cold MedicineXL3 FORTE50 in 1 BOXTABLET507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63654-601COLD MEDICINE XL3 FORTE (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE) TABLET [SELDER, S.A. DE C.V.]7Current NDC, Legacy NDC, 6 package rows20241027_51dd467b-aae8-41fa-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63654-60163654-601-04, 63654-601-50, 63654-601-02, 63654-601-20, 63654-601-01, 63654-601-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
Cold Medicine XL3 FORTEACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.51dd467b-aae8-41fa-e054-00144ff8d46c2024-10-24WarningsExact identifier
ndc (package): 63654-601-20
ndc (package): 63654-601-10
ndc (package): 63654-601-04
ndc (package): 63654-601-50
ndc (package): 63654-601-01
ndc (package): 63654-601-02
ndc (product): 63654-601
ndc11 (package): 63654060150
ndc11 (package): 63654060102
ndc11 (package): 63654060104
ndc11 (package): 63654060101
ndc11 (package): 63654060110
ndc11 (package): 63654060120
spl id: 24b211e4-a9aa-47a2-e063-6394a90aa4d3
spl set id: 51dd467b-aae8-41fa-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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