FDA Label for Nitetime Cold And Flu
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 15 ML)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Nitetime Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Meijer, 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.
Active Ingredients (In Each 15 Ml)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine Succinate 6.25 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
• nasal congestion• sinus congestion and pressure• cough due to minor throat and bronchial irritation• cough to help you sleep• minor aches and pains• headache• fever• sore throat• runny nose and sneezing• reduces swelling of nasal passages• temporarily restores freer breathing through the nose• promotes nasal and/or sinus drainage
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
• adult takes more than 4,000 mg of acetaminophen in 24 hours• child takes more than 5 doses in 24 hours• taken with other drugs containing acetaminophen• adult has 3 or more alcoholic drinks every day while using this product• skin reddening• blisters• rash
Allergy alert: 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.
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, 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.• to make a child sleepy• if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
• liver disease• heart disease• glaucoma• thyroid disease• diabetes• high blood pressure• trouble urinating due to an enlarged prostate gland• cough that occurs with too much phlegm (mucus)• a breathing problem such as emphysema or chronic bronchitis• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
• taking the blood thinning drug warfarin• taking sedatives or tranquilizers
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
Stop Use And Ask A Doctor If
• you get nervous, dizzy or sleepless• pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)• 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 headache that lasts. 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: 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
• take only as directed – see Overdose warning• only use the dose cup provided• do not exceed 4 doses per 24 hrs
Other Information
• each 15 mL contains: sodium 15 mg• store at 20-25°C (68-77°F)
Inactive Ingredients
anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C green #3, FD&C red #40, FD&C yellow #6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum
Questions?
1-800-719-9260
Package/Label Principal Display Panel
Compare to Vicks® NyQuil® Severe Honey Flavor active ingredients
meijer®
MAXIMUM STRENGTH
nitetime cold and flu
Acetaminophen
Pain Reliever | Fever Reducer
Phenylephrine HCL
Nasal Decongestant
Dextromethorphan HBr
Cough Suppressant
Doxylamine Succinate
Antihistamine
SEVERE
Multi-Symptom Relief
Honey Flavor
12 FL OZ (355 mL)
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