Indications and uses
temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep
Cold-EEZE
- Manufacturer
- ProPhase Labs, Inc. | Pharmaloz Manufacturing, Inc.
- Effective date
- 2016-01-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:44:54
Label at a glance#
ProductCold-EEZE Nighttime Cold and Flu
Active ingredientAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Label structure11 sections
Dosage and administration
do not take more than directed (see Overdose warning ) measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter Adults and children 12 years and older: 20 mL orally every 4 hours, not to exceed 6 doses in 24 hours. Children under 12 years of age: Do not use unless directed by a doctor
Storage and handling
each 20 mL contains: sodium 12 mg tamper evident: do not use if foil seal under bottle cap is open or missing store between 20-25°C (68-77°F) do not refrigerate dosing cup provided
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active Ingredients (in each 20 mL) | Purpose |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Diphenhydramine HCl 25mg | Antihistamine/cough suppressant |
| Phenylephrine HCl 10 mg | Nasal decongestant |
Uses
- temporarily relieves these common cold and flu symptoms:
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- runny nose
- sneezing
- temporarily reduces fever
- controls cough to help you get to sleep
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses in 24 hours, which is the maximum daily amount
- 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.
SPL UNCLASSIFIED SECTION
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.
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.
- with any other drug containing diphenhydramine, even one used on the skin
- if you are not 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.
- for children under 12 years of age
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma
- breathing problems such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if
- you are taking the blood thinning drug warfarin
- you are taking sedatives or tranquilizers
When using this product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness or sleeplessness occur
- pain, nasal congestion 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 persistent headache. 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.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. 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.
Directions
- do not take more than directed (see Overdose warning)
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- mL = milliliter
- Adults and children 12 years and older: 20 mL orally every 4 hours, not to exceed 6 doses in 24 hours.
- Children under 12 years of age: Do not use unless directed by a doctor
Other information
- each 20 mL contains: sodium 12 mg
- tamper evident: do not use if foil seal under bottle cap is open or missing
- store between 20-25°C (68-77°F)
- do not refrigerate
- dosing cup provided
Inactive ingredients
anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Questions?
1-800-505- 2653
(M-F: 9AM-5PM EST)
You may also report side effects to this phone number
SPL UNCLASSIFIED SECTION
Distributed by:
ProPhase Labs, Inc.
PO Box 1349
Doylestown, PA 18901
PRINCIPAL DISPLAY PANEL - 266 mL Bottle Label
MAXIMUM STRENGTH
Cold-EEZE®
NIGHTTIME
Cold & Flu
Acetaminophen 650 mg • Pain Reliever/Fever Reducer
Diphenhydramine HCl 25 mg • Antihistamine/Cough Suppressant
Phenylephrine HCl 10 mg • Nasal Decongestant
MULTI-SYMPTOM
Relief of:
- Headache, Aches, Fever & Sore Throat
- Cough
- Nasal Congestion
- Sneezing and Runny Nose
For Ages 12+
9 fl oz (266 mL)
3001000209-47007
NDC 61941-0301-1
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1375932 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 1 |
| 1375932 | acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 1 |
| 1375932 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 1 |
| 1375932 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 1 |
| 1375932 | APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 1 |
| 1375932 | APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 1 |
| 1375932 | APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61941-0301-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8b6c-f424-e053-dadaa90a57ce | Cold-EEZE ® Nighttime Cold & Flu |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61941-0301-1 | Cold-EEZE Nighttime Cold and Flu | 266 mL in 1 BOTTLE, UNIT-DOSE | LIQUID | 266 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61941-0301 | COLD-EEZE NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PROPHASE LABS, INC.] | 1 | Legacy NDC, 1 package rows | 20160205_d3c2bcaf-e54a-480c-9e10-f266407f0095.zip |
Products#
Every source-derived product name is available through these pages.
- Cold-EEZE Nighttime Cold and Flu
- Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
- Acetaminophen
- Diphenhydramine Hydrochloride
- Diphenhydramine
- Phenylephrine Hydrochloride
- Phenylephrine
- Anhydrous Citric Acid
- Edetate Disodium
- FD&C Blue NO. 1
- FD&C Red NO. 40
- Glycerin
- Propylene Glycol
- Propyl Gallate
- Water
- Sodium Benzoate
- Sodium Citrate, Unspecified Form
- Sorbitol
- Sucralose
- Xanthan Gum
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61941-0301 | 61941-0301-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| be7d15b9-9e4b-4dff-aad4-ea5b7df188db | d3c2bcaf-e54a-480c-9e10-f266407f0095 | 2016-01-29 | Warnings | be7d15b9-9e4b-4dff-aad4-ea5b7df188db d3c2bcaf-e54a-480c-9e10-f266407f0095 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.