Day Time Cold & Flu Relief

Manufacturer
AptaPharma Inc.
Effective date
2026-05-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:56:44

Label at a glance#

ProductDay-Time Cold/Flu Relief
Active ingredientAcetaminophen, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure18 sections

Indications and uses

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

Dosage and administration

■ take only as recommended (see overdose warning) ■ use dosage cup or tablespoon (TBSP) ■ do not exceed 4 doses per 24 hours                      age                                                dose adults & children 12 years and over               30 mL (2 TBSP) every 4 hours children 6 to under 12 years                           15 mL (1 TBSP) every 4 hours children 4 to under 6 years                         ...

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 these common cold/flu symptoms:
■ minor aches and pains ■ headache ■ sore throat ■ fever
■ nasal congestion ■ cough due to minor throat and bronchial irritation

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes: ■ more than
4 doses in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing
acetaminophen ■ 3 or more alcoholic drinks everyday while usina 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, persists 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

■ 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product. ■ for more than 10 days for pain unless directed by a doctor. ■ for more than 3 days for fever unless directed by a doctor. ■ with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacists.

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 prostrate gland
■ persistent or chronic cough such as occurs with smoking, asthma, or
emphysema ■ cough accompanied by excessive phlegm (mucus)

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
■ new symptoms occur
■ fever gets worse or lasts more than 3 days
■ pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
■ redness or swelling is present
■ cough comes back or occurs with rash or headache that lasts.
These couldbe signs of a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Overdose Warning:

OVERDOSAGE SECTION

Taking more than the recommended dose (overdose) may
cause liver damage. In case of accidental overdose, get medical help or contact
a Poison Control Center 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

■ take only as recommended (see overdose warning)
■ use dosage cup or tablespoon (TBSP)
■ do not exceed 4 doses per 24 hours

                     age                                                dose
adults & children 12 years and over               30 mL (2 TBSP) every 4 hours
children 6 to under 12 years                           15 mL (1 TBSP) every 4 hours
children 4 to under 6 years                              ask a doctor
children under 4 years                                     do not use

When using Day Time and Night Time products, carefully read each label to
ensure correct dosing.

Other information

OTHER SAFETY INFORMATION

■ sodium content per tablespoon: 10 mg
■ store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C Yellow # 6, Made in USA flavor, glycerin, propylene glycol, purified water,
saccharin sodium, sodium benzoate, sucrose

Questions?

OTC - QUESTIONS SECTION

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

Product Package Label - Day Time Cold & Flu Relief

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AP SAFE

*COMPARE TO
the active ingredients in
VICKS® DAYQUIL®

Day Time

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

Cold & Flu Relief

Multi-Symptom Relief

12 FL OZ (354 mL)

*This product is not manufactured or distributed by Procter &
Gamble, owner of the registered trademark Vicks® DayQuil®.

Manufactured by: AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110

           LOT:                                  EXP:

12 OZ

506-28 12OZ506-28 12OZ

​6 OZ

6oz6oz

6ozz6ozz

res

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130376281506259GTIN-13: 0376281506259
EAN-13: 0376281506259
GTIN-12: 376281506259
UPC-A: 376281506259
GTIN storage (14 digits): 00376281506259
506-25 6oz.jpg
BarcodeEAN-130376281506280GTIN-13: 0376281506280
EAN-13: 0376281506280
GTIN-12: 376281506280
UPC-A: 376281506280
GTIN storage (14 digits): 00376281506280
506-28 12oz Botl.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76281-506-25Day-Time Cold/Flu Relief177 mL in 1 BOTTLELIQUID1775
76281-506-28Day-Time Cold/Flu Relief354 mL in 1 BOTTLE, PLASTICLIQUID3545

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
76281-50676281-506-28, 76281-506-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
Day-Time Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.c0dc613c-7f4e-4733-b2b6-6ba20e8fb83c2026-05-10WarningsExact identifier
ndc (package): 76281-506-28
ndc (package): 76281-506-25
ndc (product): 76281-506
ndc11 (package): 76281050628
ndc11 (package): 76281050625
spl id: ef99a9d8-895c-403a-813b-4ca8797b2ae8
spl set id: c0dc613c-7f4e-4733-b2b6-6ba20e8fb83c

Reported adverse events (FAERS/openFDA)#

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