FDA Label for Walgreen Nighttime Cold And Flu
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT:
- SORE THROAT WARNING
- 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
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 354ML BOTTLE LABEL
Walgreen Nighttime Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens Co.. 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
Active ingredients (in each 15 mL)
In case of overdose, get medical help or contact a Poison Control Center right away at 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.
Distributed by:
Otc - Active Ingredient
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Otc - Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
• nasal congestion• sinus congestion & pressure• cough due to minor throat & bronchial irritation• cough to help you sleep• minor aches & pains• headache• fever• sore throat• runny nose & sneezing• reduces swelling of nasal passages• temporarily restores freer breathing through the nose• promotes nasal and/or sinus drainage
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if
• adults take more than 4 doses (30mL each) in 24 hours, which is the maximum daily amount for this product• taken with other drugs containing acetaminophen• adults has 3 or more alcoholic drinks every day 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.• 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 child sleepy
Ask A Doctor Before Use If You Have
• liver disease• heart disease• high blood pressure• thyroid disease• diabetes• glaucoma• cough that occurs with too much phlegm (mucus)• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema• trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
• taking sedatives or tranquilizers• taking the blood thinning drug warfarin
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.
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.
Directions
• take only as directed• only use the dose cup provided• do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over | 30 mL every 4 hrs |
children 6 to under 12 yrs | 15 mL every 4 hrs |
children 4 to under 6 yrs | do not use unless directed by a doctor |
children under 4 years | Do not use |
Other Information
• each 15 mL contains: sodium 9 mg• Store at room temperature.• Do not refrigerate.
Inactive Ingredients
citric acid, D&C Yellow No. 10, disodium edetate, FD&C Green No. 3, FD&C Red No. 40, flavors, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.
Questions?
1-866-467-2748
Principal Display Panel - 354Ml Bottle Label
*Compare to the active ingredients inVICKS® NyQuil™ Severe Cold & Flu Honey Flavor
NDC 0363-6111-12
Nighttime
Cold & Flu
Relief
Acetaminophen- Pain reliever/Fever reducer
Phenylephrine HCl – Nasal decongestant
Doxylamine Succinate - Antihistamine
Dextromethorphan HBr – Cough suppressant
• Headache, Fever, Sore Throat,Minor Aches & Pains
• Nasal Congestion & Sinus Pressure• Sneezing, Runny Nose• Cough
Honey Flavor
Naturally and Artificially Flavored
12 FL OZ (354 ml)
* Please review the disclaimer below.