COLD-EEZE DAYTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
ProPhase Labs, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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 |
Uses
- 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
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.
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.
- for children under 12 years of age
- 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.
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
- 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
When using this product
-
do not use more than directed
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.
If pregnant or breast-feeding, ask a health professional before use.
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 15-30°C (59-86°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
Distributed by:
ProPhase Labs, Inc.
PO Box 1349
Doylestown, PA 18901
PRINCIPAL DISPLAY PANEL - 266 mL Bottle Label
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:
- ✓
-
Headache, Fever, Sore Throat & Aches & Pains
- ✓
-
Nasal/Sinus Congestion, Sinus Pressure
- ✓
-
Cough, Chest Congestion
- ✓
-
Thins & Loosens Mucus
For Ages 12+
9 fl oz (266 mL)
3001000211-47005
NDC 61941-0300-1
ProPhase Labs, Inc.