XL-3 Day Time

Manufacturer
AptaPharma Inc.
Effective date
2023-12-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:06:07

Label at a glance#

ProductXL-3 Day Time
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure18 sections

Indications and uses

temporarily relieves common cold and flu symptoms: • nasal congestion • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each 15 mL, 1 tablespoon)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough Suppressant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold and flu symptoms:
• nasal congestion • cough due to minor throat and bronchial
irritation • sore throat • headache • minor aches and pains • fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks every day while using this product.

Allergy 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.

Sore throat warning: If sore throat is severe, lasts for more than 2 days, is
accompanied or followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

• with any other products containing acetaminophen (prescription or nonprescription). lf you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • for more than10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by 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 for 2 weeks after stopping the MAOI drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• liver disease
• heart disease • thyroid disease • diabetes • high blood pressure
• trouble urinating due to enlarged prostate gland • cough accompanied by
excessive phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

• do not use more than directed (see
overdose warning) • avoid alcoholic drinks

Stop use and ask a doctor if

OTC - STOP USE SECTION

• you get nervous, dizzy or sleepless
• symptoms get worse or last more than 5 days (children) or 7days (adults)
• fever gets worse or lasts more than 3 days • redness or swelling is
present • new symptoms occur • cough comes back, or occurs with
rash or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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 the recommended dose
(overdose) may cause serious health problems including liver damage.
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 children even if
you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions • take only as directed - see Overdose warning
• use dose cup or tablespoon • do not exceed 4 doses per 24 hours
• if taking Day Time during the day and Night Time at night, limit total to
4 doses per 24 hours

adults & children 12 years and over        30 mL (2 TBSP) every 4 hours

children 6 to under 12 years                 15mL (1TBSP) every 4 hours

children 4 to under 6 years                   ask a doctor

children under 4 years                         do not use

Other information

OTHER SAFETY INFORMATION

• Sodium content per tablespoon: 10mg
• store at 20°-25°C (68°-77° F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

 citric acid, FD & C Yellow No.6, flavor, glycerin,
propylene glycol, purified water, saccharin sodium, sodium benzoate, sucrose.

Questions or Comments?

OTC - QUESTIONS SECTION

Call weekdays from 9:30 AM to 4:30 PM EST
1-877-798-5944

Principal Display Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

XL-3 Day TimeXL-3 Day Time

XL-3 Day Time 2XL-3 Day Time 2

XL-3*
Day Time
Non-Drowsy Cold/Flu relief

COLD MEDICINE

• Acetaminophen - Pain Reliever/Fever Reducer
• Dextromethorphan HBr - Cough Suppressant
• Phenylephrine HCI - Nasal Decongestant

Fast Relief of:
NASAL CONGESTION
FEVER
ACHES & PAINS
SORE THROAT
COUGH                       

12 FL OZ (354 mL)    Orange Flavor

XL-3*
Day Time
Non-Drowsy Cold/Flu relief

COLD MEDICINE

• Acetaminophen - Pain Reliever/Fever Reducer
• Dextromethorphan HBr - Cough Suppressant
• Phenylephrine HCI - Nasal Decongestant

Fast Relief of:
NASAL CONGESTION
FEVER
ACHES & PAINS
SORE THROAT
COUGH                  

12 FL OZ (354 mL)          Orange Flavor

XL-3* Day Time

COLD MEDICINE

DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences

Drug Facts

Active ingredients                                                                   Purpose
(in each 15 mL, 1 tablespoon)
Acetaminophen 325 mg ........................ Pain reliever/fever reducer
Dextromethorphan HBr 10 mg .........................Cough Suppressant
Phenylephrine HCI 5 mg .................................Nasal decongestant

Uses temporarily relieves common cold and flu symptoms:
• nasal congestion • cough due to minor throat and bronchial
irritation • sore throat • headache • minor aches and pains • fever

→ DRUG FACTS CONTINUED ON BACK →

Distributed by:
Midway Importing, Inc.
1807 Brittmoore Road,
Houston, TX 77043 1-800-531-3873
Made in USA
                                    Peel
LR-059 REV 03             back ►

XL-3* Day Time

COLD MEDICINE

Drug Facts (continued)

Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks every day while using this product.
Allergy 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.
Sore throat warning: If sore throat is severe, lasts for more than 2 days, is
accompanied or followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.

Do not use • with any other products containing acetaminophen (prescription or nonprescription). lf you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • for more than10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by 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 for 2 weeks after stopping the MAOI drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have • liver disease
• heart disease • thyroid disease • diabetes • high blood pressure
• trouble urinating due to enlarged prostate gland • cough accompanied by
excessive phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. ►

Drug Facts (continued)

When using this product • do not use more than directed (see
overdose warning) • avoid alcoholic drinks

Stop use and ask a doctor if • you get nervous, dizzy or sleepless
• symptoms get worse or last more than 5 days (children) or 7days (adults)
• fever gets worse or lasts more than 3 days • redness or swelling is
present • new symptoms occur • cough comes back, or occurs with
rash or headache that lasts. These could be signs of a serious condition.

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 serious health problems including liver damage.
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 children even if
you do not notice any signs or symptoms.

Directions • take only as directed - see Overdose warning
• use dose cup or tablespoon • do not exceed 4 doses per 24 hours
• if taking Day Time during the day and Night Time at night, limit total to
4 doses per 24 hours
___________________________________________________________
adults & children 12 years and over │ 30 mL (2 TBSP) every 4 hours
___________________________________________________________
children 6 to under 12 years            │ 15mL (1TBSP) every 4 hours
___________________________________________________________
children 4 to under 6 years              │ ask a doctor
___________________________________________________________
children under 4 years                     │ do not use
___________________________________________________________
Other information • Sodium content per tablespoon: 10mg
• store at 20°-25°C (68°-77° F).

Inactive ingredients citric acid, FD & C Yellow No.6, flavor, glycerin,
propylene glycol, purified water, saccharin sodium, sodium benzoate, sucrose.

Questions or Comments? Call weekdays from 9:30 AM to 4:30 PM EST
1-877-798-5944


XL-3*
Day Time
Non-Drowsy Cold/Flu relief

COLD MEDICINE

• Acetaminophen - Pain Reliever/Fever Reducer
• Dextromethorphan HBr - Cough Suppressant
• Phenylephrine HCI - Nasal Decongestant

Fast Relief of:
NASAL CONGESTION
FEVER
ACHES & PAINS
SORE THROAT
COUGH                       

 6 FL OZ (177 mL)                                           Orange Flavor

XL-3 6_OZXL-3 6_OZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN5
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD5
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY5
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY5
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - 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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76281-304-28XL-3 Day Time354 mL in 1 BOTTLE, PLASTICLIQUID3545
76281-306-25XL-3 Day Time177 mL in 1 BOTTLE, PLASTICLIQUID1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76281-304XL-3 DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [APTAPHARMA INC.]5Current NDC, Legacy NDC, 1 package rows20231231_94e02be4-b8a6-422a-8f66-e6a69e924b2c.zip
76281-306XL-3 DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [APTAPHARMA INC.]5Current NDC, Legacy NDC, 1 package rows20231231_94e02be4-b8a6-422a-8f66-e6a69e924b2c.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76281-30476281-304-28
76281-30676281-306-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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
XL-3 Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.94e02be4-b8a6-422a-8f66-e6a69e924b2c2023-12-30WarningsExact identifier
ndc (package): 76281-304-28
ndc (package): 76281-306-25
ndc (product): 76281-306
ndc (product): 76281-304
ndc11 (package): 76281030428
ndc11 (package): 76281030625
spl id: 2fc9865d-66d5-4fb0-9ea8-82f5981b6562
spl set id: 94e02be4-b8a6-422a-8f66-e6a69e924b2c

Reported adverse events (FAERS/openFDA)#

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