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#
Contacts and useful links#
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
------------------------------------------------------
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.
resRes
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 1 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 1 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76281-603-03 | Night Time Cold and Flu relief liquid filled softgels | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 1 | |
| 76281-603-03 | Night Time Cold and Flu relief liquid filled softgels | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 1 |
Products#
Every source-derived product name is available through these pages.
- Night Time Cold and Flu relief liquid filled softgels
- Acetaminophen,Dextromethrophan HBR,Doxylamine Succinate
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- SORBITAN
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76281-603 | 76281-603-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Night Time Cold and Flu relief liquid filled softgels | ACETAMINOPHEN,DEXTROMETHROPHAN HBR,DOXYLAMINE SUCCINATE | AptaPharma Inc. | d61e2186-8b59-45f9-96ec-83430a0fe0cb | 2026-05-10 | Warnings | 76281-603-03 76281-603 76281060303 8f4959ca-8471-47a4-bd2d-f22d639396cf d61e2186-8b59-45f9-96ec-83430a0fe0cb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
