temporarily relieves these common cold and flu symptoms: nasal congestion sinus congestion and pressure cough due to minor throat and bronchial irritation minor aches and pains sore throat headache temporarily reduces fever temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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
each 20 mL contains: sodium 12 mg tamper evident: do not use if foil seal under bottle cap is open or missing store between 15-30°C (59-86°F) do not refrigerate dosing cup provided
Drug Facts
| Active Ingredients (in each 20 mL) | Purpose |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Guaifenesin 400 mg | Expectorant |
| Phenylephrine HCl 10 mg | Nasal decongestant |
This product contains acetaminophen. Severe liver damage may occur if you take:
Acetaminophen may cause severe skin reactions.
Symptoms may include:
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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
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.
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
1-800-505- 2653
(M-F: 9AM-5PM EST)
You may also report side effects to this phone number
Distributed by:
ProPhase Labs, Inc.
PO Box 1349
Doylestown, PA 18901
MAXIMUM STRENGTH
Cold-EEZE®
Daytime Cold & Flu
Acetaminophen 650 mg • Pain Reliever/Fever Reducer
Phenylephrine HCl 10 mg • Nasal Decongestant
Dextromethorphan HBr 20 mg • Cough Suppressant
Guaifenesin 400 mg • Expectorant
MULTI-SYMPTOM
Relief of:
For Ages 12+
9 fl oz (266 mL)
3001000211-47005
NDC 61941-0300-1
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 1 |
| 1116572 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 1 |
| 1116572 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 1 |
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 1 |
| 1116572 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61941-0300-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-53fe-f424-e053-dadaa90a57ce | Cold-EEZE ® Daytime Cold & Flu |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61941-0300-1 | Cold-EEZE Daytime Cold and Flu | 260 mL in 1 BOTTLE, UNIT-DOSE | LIQUID | 260 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61941-0300 | COLD-EEZE DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PROPHASE LABS, INC.] | 1 | Legacy NDC, 1 package rows | 20160204_e68e3480-0e4d-4fa5-8840-91207034f5f0.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61941-0300 | 61941-0300-1 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| fa35352a-3f97-4e21-be20-86ee94fc4919 | e68e3480-0e4d-4fa5-8840-91207034f5f0 | 2016-01-28 | Warnings | fa35352a-3f97-4e21-be20-86ee94fc4919 e68e3480-0e4d-4fa5-8840-91207034f5f0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.