AP SAFE Night-Time Cold/Flu 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#

ProductNight Time Cold and Flu relief liquid filled softgels
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure17 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredients 
(in each Softgel)
Acetaminophen 325 mg............. Pain reliever/Fever reducer
Dextromethorphan HBr 15 mg..... Cough suppressant
Doxylamine succinate 6.25 mg ..... Antihistamine

INDICATIONS & USAGE SECTION

Uses
Temporarily relieves common cold/flu symptoms:

OTC - PURPOSE SECTION

• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pain
• fever
• runny nose & sneezing

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: •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 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 •to make a child sleep

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
• liver disease •glaucoma •cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product do not use more than directed.• excitability may occur, especially in children,
• marked drowsiness may occur •avoid alcoholic drinks •be careful when driving a motor vehicle or operating
machinery •alcohol, sedatives, and tranquilizers may increase drowsiness

OTC - STOP USE SECTION

Stop use and ask a doctor if 

•pain or cough gets worse or lasts more than 7 days •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 accidental overdose, get medical help or contact a Poison Control Center right
away. Quick medical attention is critical for aduits as well as for 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 soft gels with water every 6 hours
Children 4 to under 12 years:  Ask a doctor
Children under 4 years:  Do not use

OTC - WHEN USING SECTION

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

Inactive ingredients
D&C Yellow # 10, FD&C Blue # 1, 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 Night time cold/flu Softgels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

AP SAFE​® Nighttime                                                                              *Compare to the active ingredients

Cold/Flu Relief                                                                                        In Vicks​​® Nyquil​™ Cold & Flu Nighttime

                                                                                                                Relief LiquiCaps™

Acetaminophen

Dextromethorphan HBr/Doxylamine Succinate

 24 Softgels

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​® Nyquil​™ Liquicaps​™

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 WARNING AND PRODUCT INFORMATION.

603603

resRes

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN1
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD1
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76281-603-03Night Time Cold and Flu relief liquid filled softgels2 in 1 CARTONCAPSULE, LIQUID FILLED21
76281-603-03Night Time 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
76281-60376281-603-03

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
Night Time Cold and Flu relief liquid filled softgelsACETAMINOPHEN,DEXTROMETHROPHAN HBR,DOXYLAMINE SUCCINATEAptaPharma Inc.d61e2186-8b59-45f9-96ec-83430a0fe0cb2026-05-10WarningsExact identifier
ndc (package): 76281-603-03
ndc (product): 76281-603
ndc11 (package): 76281060303
spl id: 8f4959ca-8471-47a4-bd2d-f22d639396cf
spl set id: d61e2186-8b59-45f9-96ec-83430a0fe0cb

Reported adverse events (FAERS/openFDA)#

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