Nighttime Cold/Flu Relief
- Manufacturer
- ARMY AND AIR FORCE EXCHANGE SERVICE | AptaPharma Inc.
- Effective date
- 2025-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:27:03
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
Dextromethorphan HBr ......15 mg
Doxylamine succinate .........6.25 mg
OTC - PURPOSE SECTION
Purpose
Acetaminophen ........................Pain reliever/Fever reducer
Dextromethorphan HBr .............Cough suppressant
Doxylamine succinate ............... Antihistamine
INDICATIONS & USAGE SECTION
Usestemporarily relieves common cold/flu
symptoms: ■ cough due to minor throat &
bronchial irritation ■ sore throat ■ headache
■ minor aches and pain ■ fever ■ runny
nose and sneezing
WARNINGS SECTION
WarningsLiver warning
: This product
contains acetaminophen. Severe liver
damage may occur if you take ■ more than
4doses in 24 hrs, 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 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 products 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 useif 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 an enlarged prostate
gland
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacistbefore 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 overdose, get medical help or contact a
Poison Control Center right away.
OVERDOSAGE SECTION
In case of accidental 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 &
| 2 soft gels with water every 6 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.
OTHER SAFETY INFORMATION
Other information
■ Store at room temperature 20-25º C (68-77º 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: exchange select NightTime Cold/Flu Relief
exchange select
Nighttime
Cold/Flu Relief
24 Softgels
Manufactured For Your Military Exchange
By AptaPharma Inc.,
1533 Union Avenue, Pennsauken, NJ 08110
1-877-798-5944
aptapharma.com
res
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 | 4 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 4 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 4 |
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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55301-603-03 | Nighttime Cold/Flu Relief | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 4 | |
| 55301-603-03 | Nighttime Cold/Flu Relief | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 4 |
Products#
Every source-derived product name is available through these pages.
- Nighttime Cold/Flu Relief
- ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- SORBITAN
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55301-603 | 55301-603-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| 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 |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Nighttime Cold/Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | ARMY AND AIR FORCE EXCHANGE SERVICE | 029e6215-b72d-4fd0-8918-db1abcc4490a | 2025-12-19 | Warnings | 55301-603-03 55301-603 55301060303 4652ed1a-8024-2fa2-e063-6394a90a8d0f 029e6215-b72d-4fd0-8918-db1abcc4490a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
