GoodMeds Nighttime Cold and Flu - Cabinet Health P.B.C.
- Manufacturer
- Cabinet Health P.B.C.
- Effective date
- 2026-08-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-10-07 01:02:28
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Acetaminophen 500 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
OTC - PURPOSE SECTION
Pain reliever/fever reducer
Cough suppressant
Antihistamine
INDICATIONS & USAGE SECTION
Uses
temporarily relieves common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- fever
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
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 every day 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, persists for more than 2 days, is accompanied or 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, 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
- 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 the blood thinning drug warfarin
- taking sedatives or tranquilizers.
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
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- 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.
OVERDOSAGE SECTION
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
- Do not exceed 8 softgels per 24 hrs.
- Take only as directed
| Adults & children age 12 yrs & over |
|
| Children 4 to under 12 yrs |
|
| Children under 4 yrs |
|
OTHER SAFETY INFORMATION
Other information
- Store at room temperature between 20–25°C (68–77°F)
- avoid excessive heat
INACTIVE INGREDIENT SECTION
Inactive Ingredients
FD&C Blue #1, FD&C Yellow #10, Gelatin, Glycerin, Polyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Sorbitan solution
OTC - QUESTIONS SECTION
Questions or comments? Call 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Package Display
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0850069928353 | GTIN-13: 0850069928353 EAN-13: 0850069928353 GTIN-12: 850069928353 UPC-A: 850069928353 GTIN storage (14 digits): 00850069928353 | GM_Cold_FluNighttime_48count_2026-08-18_rh.jpg |
Products#
Every source-derived product name is available through these pages.
- GoodMeds Nighttime Cold and Flu
- Acetaminophen 325mg, Dextromethorphan HBr 15mg, Doxylamine Succinate 6.25mg
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- POLYETHYLENE GLYCOL 400
- PROPYLENE GLYCOL
- POVIDONE K30
- WATER
- GELATIN
- GLYCERIN
- SORBITOL
- SORBITAN
- YELLOW 10
- FD&C BLUE NO. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82725-4106 | 82725-4106-1 |
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 |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| WATER | 059QF0KO0R | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITOL | 506T60A25R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| YELLOW 10 | 35SW5USQ3G | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
