Cold Medicine

Manufacturer
Midway Importing, Inc. | Selder, 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 00:30:04

Label at a glance#

ProductCold Medicine XL3
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 ■ Adults and children 12 years of age and older: take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours ■ Children under 12 years of age: do not use in children under 12 years of age; this will provide more than the recommended dose (overdoes) and may cause liver damage.

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylepherine HCl 5 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 12 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 ■ 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 contains 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.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 use more than directed ■ Adults and children 12 years of age and older: take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours ■ Children under 12 years of age: do not use in children under 12 years of age; this will provide more than the recommended dose (overdoes) and may cause liver damage.

Other Information

SPL UNCLASSIFIED SECTION

■ store at room temperature in a dry place ■ do not use if blister package is torn.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alcohol, croscarmellose sodium, hypromellose, lactose monhydrate (derived from milk), magnesium stearate, polyethylene glycol, purified water, talc, titanium dioxide

Questions and Comments?

OTC - QUESTIONS SECTION

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
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral TabletPSN2
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD2
1046781APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSY2

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
76095-011-20Cold MedicineXL32 in 1 BOXTABLET22
76095-011-20Cold MedicineXL310 in 1 BLISTER PACKTABLET102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76095-011COLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE) TABLET [MIDWAY IMPORTING, INC.]2Current NDC, Legacy NDC, 2 package rows20241027_e41b9beb-e274-5c02-e053-2995a90ad0f8.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76095-01176095-011-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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 XL3ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDEMidway Importing, Inc.e41b9beb-e274-5c02-e053-2995a90ad0f82024-10-17WarningsExact identifier
ndc (package): 76095-011-20
ndc (product): 76095-011
ndc11 (package): 76095001120
spl id: 24b2650e-08a2-0752-e063-6394a90a4b90
spl set id: e41b9beb-e274-5c02-e053-2995a90ad0f8

Reported adverse events (FAERS/openFDA)#

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