FDA Label for Cold-eeze Nighttime Cold And Flu
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 266 ML BOTTLE LABEL
Cold-eeze Nighttime Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Prophase Labs, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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.
Distributed by:
ProPhase Labs, Inc.
PO Box 1349
Doylestown, PA 18901
Otc - Purpose
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
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.
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
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
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
* Please review the disclaimer below.