Cold Medicine

Manufacturer: Selder, S.A. de C.V.
Effective date: 2011-10-20
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:30:07

Label at a glance#

ProductCold Medicine XL3

Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE

Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each capsule)
Acetaminophen 325 mg
Chlorpheniramine Maleate 4 mg
Phenylepherine Hydrochloride 10 mg

OTC - PURPOSE SECTION

Purpose
Analgesic
Antihistamine
Decongestant

INDICATIONS & USAGE SECTION

Uses temporarily relieves these symptoms due to common cold and allergies: • nasal congestion • runny nose • sneezing • watery eyes • fever • aches and pains

WARNINGS SECTION

Warnings
Do exceedrecommended dosage

OTC - ASK DOCTOR SECTION

Ask a doctor before use you have
• glaucoma • breathing problem such as emphysema or chronic bronchitis • heart disease • diabetes • thyroid disease
• difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives

OTC - STOP USE SECTION

Stop taking this product and ask a doctor if you have • pain • fever or symptoms that persist or get worse • new symptoms occur
• redness or swelling • these may be signs of a serious condition.

OTC - WHEN USING SECTION

When using this product
• you may get drowsy • avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

If nervousness, dizziness or sleeplessness occur discontinue use and consult a doctor

If symptoms do not improve within 7 days, or are accompanied by fever, consult a doctor

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

SPL UNCLASSIFIED SECTION

Drug Interaction Precautions
• Do not use if you are 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.

DOSAGE & ADMINISTRATION SECTION

Directions 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, unless directed by a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients Lactose, stearic acid, povidone, hydroxypropylmethylcellulose, polyethylene glycol, titanium dioxide, FDC Yellow No. 5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1193293	Acetaminophen/Chlorpheniramine/Phenylephrine (Oral Pill)	acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1193293	acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	1
1193293	acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	1
1193293	APAP 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CHLORPHENIRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63654-600-02	2019-11-13	C162847	48780-1	97449f38-c6d7-f6ea-e053-dbdaa90aa703	Drug Facts
63654-600-68	2019-11-13	C162847	48780-1	97449f38-c6d7-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63654-600-02	Cold MedicineXL3	25 in 1 BLISTER PACK	TABLET	25		1
63654-600-68	Cold MedicineXL3	20 in 1 BLISTER PACK	TABLET	20		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63654-600	COLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE ) TABLET [SELDER, S.A. DE C.V.]	1	Legacy NDC, 2 package rows	20111115_fc4d100b-eaa9-4e46-a27a-74094aa11d0f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	1
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	1
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Cold Medicine XL3
Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
ACETAMINOPHEN
LACTOSE
STEARIC ACID
POVIDONE
HYPROMELLOSES
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
FD&C YELLOW NO. 5
CHLORPHENIRAMINE MALEATE
CHLORPHENIRAMINE
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63654-600	63654-600-68, 63654-600-02

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
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
LACTOSE	J2B2A4N98G	IACT
STEARIC ACID	4ELV7Z65AP	IACT
POVIDONE	FZ989GH94E	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
CHLORPHENIRAMINE MALEATE	V1Q0O9OJ9Z	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB

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 4 · 181 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	JELLY / TOPICAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	INSERT, EXTENDED RELEASE / OPHTHALMIC	0.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / BUCCAL	6 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SOLUTION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GEL / RECTAL		348 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE / ORAL	652 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL		216 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SYRUP / ORAL	0.1 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		350 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	193.8 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	INJECTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / SUBLINGUAL		352 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / RESPIRATORY (INHALATION)	44.4 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, FILM COATED / ORAL	1.68 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, CHEWABLE / ORAL	4.5 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GRANULE / ORAL		45 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, COATED / ORAL	7.93 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAMUSCULAR	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SHAMPOO / TOPICAL	3 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	CONCENTRATE / BUCCAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, ORALLY DISINTEGRATING / ORAL		41 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	POWDER, FOR SUSPENSION / ORAL	35 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / VAGINAL		1088 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	ELIXIR / ORAL	0.15 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / RECTAL	8 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	17 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / OPHTHALMIC	0.5 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
09cc48f3-e043-4da8-a9f1-00cb6ccbee95			fc4d100b-eaa9-4e46-a27a-74094aa11d0f	2011-10-20	Warnings	Exact identifier spl id: 09cc48f3-e043-4da8-a9f1-00cb6ccbee95 spl set id: fc4d100b-eaa9-4e46-a27a-74094aa11d0f

Reported adverse events (FAERS/openFDA)#

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