AP SAFE Day Time Multi-Symptom Cold & Flu Relief Softgels

Manufacturer
AptaPharma Inc.
Effective date
2026-05-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:56:44

Label at a glance#

ProductDaytime Cold and Flu Relief Liquid Filled Softgels
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Storage and handling

Other information •store at room temperature 20-25°C (68-77°F) •avoid excessive heat

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredients
(in each Softgel)
Acetaminophen           325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl          5 mg

OTC - PURPOSE SECTION

Purposes
Acetaminophen               Pain reliever/Fever reducer
Dextromethorphan HBr    Cough suppressant
Phenylephrine HCl 5 mg   Nasal Decongestant

INDICATIONS & USAGE SECTION

Uses
Temporarily relieves common cold/flu symptoms:
• nasal congestion
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pain
• fever

WARNINGS SECTION

Warnings


Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take•more than 8 softgels in
24 hours, which is the maximum daily amount for this product •with other drugs containing acetaminophen •3 or
more alcoholic drinks daily 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, occurs with or is followed by fever, headache,
rash, nausea or vomiting, consult a doctor promptly.

OTC - DO NOT USE SECTION

Do not use: • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure
whether a drug contains acetaminophen, ask a doctor or pharmacist • 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 drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or
pharmacist before taking this product.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product, do not use more than directed.

OTC - STOP USE SECTION

Stop use and ask a doctor if
• you get nervous, dizzy or sleepless • symptoms get worse or last more than 5 days (children) or 7 days (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.

In case of overdose, get medical help or contact a Poison Control Center right away.  Quick 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 Warning)
• do not exceed 4 doses per 24 hours
Adults & Children 12 years & over:         2 softgels with water every 4 hours
Children 4 to under 12 years:                    Ask a doctor
Children under 4 years:                             Do not use

• When using other DayTime or Nighttime products, carefully read each label to ensure correct dosing.

STORAGE AND HANDLING SECTION

Other information
•store at room temperature 20-25°C (68-77°F)
•avoid excessive heat

INACTIVE INGREDIENT SECTION

Inactive ingredients
FD&C Red # 40, FD&C Yellow # 06, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water,
Sorbitol sorbitan solution, titanium dioxide.

OTC - QUESTIONS SECTION

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

Product Label: AP SAFE Day Time Multi-Symptom Cold & Flu Relief Softgels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

------------------------------------------------------

AP SAFE​®                                                                                              *Compare to the active ingredients

DayTime                                                                                                 In Vicks® Dayquil

Cold/Flu Relief                                                                                      Cold & Flu LiquiCaps

Acetaminophen

Dextromethorphan HBr / Phenylephrine HCI

24 Softgels

• Headache, Fever,Sore Throat,
   Minor Aches & Pains
• Nasal Congestion,
   Sinus Pressure
• Cough

Manufactured by AptaPharma Inc.,

1533 Union Ave., Pennsauken, NJ 08110

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

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF
TAMPERING.


KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

604-03 Carton604-03 Carton

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN1
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD1
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY1

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
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
76281-604-03Daytime Cold and Flu Relief Liquid Filled Softgels2 in 1 CARTONCAPSULE, LIQUID FILLED21
76281-604-03Daytime Cold and Flu Relief Liquid Filled Softgels12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76281-60476281-604-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
Daytime Cold and Flu Relief Liquid Filled SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.c078efb5-d30e-4dd1-a600-6e827390df762026-05-10WarningsExact identifier
ndc (package): 76281-604-03
ndc (product): 76281-604
ndc11 (package): 76281060403
spl id: f10b797a-ee8b-49ff-96df-1944d4b37ebe
spl set id: c078efb5-d30e-4dd1-a600-6e827390df76

Reported adverse events (FAERS/openFDA)#

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