FDA Label for Daytime Nighttime Severe Cold And Flu Relief
View Indications, Usage & Precautions
- NIGHTTIME SEVERE COLD & FLUACTIVE INGREDIENTS (IN EACH 30 ML)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK 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 OR COMMENTS?
- DAYTIME SEVERE COLD & FLUACTIVE INGREDIENTS – (IN EACH 15 ML)
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Daytime Nighttime Severe Cold And Flu Relief Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid Corporation. 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.
Nighttime Severe Cold & Fluactive Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCl 10 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
• nasal congestion• sinus congestion and pressure• minor aches and pains• headache• fever• sore throat• runny nose and sneezing• cough due to minor throat and bronchial irritation• cough to help you sleep• reduces swelling of nasal passages• promotes nasal and/or sinus drainage• temporarily restores freer breathing through the nose• nasal congestion• sinus congestion and pressure• cough due to minor throat and bronchial irritation• minor aches and pains• headache• fever• sore throat• reduces swelling of nasal passages• temporarily restores freer breathing through the nose• 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
temporarily relieves common cold/flu symptoms:
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4,000 mg of acetaminophen in 24 hours• with other drugs containing acetaminophen• 3 or more alcoholic drinks every day while using this product• skin reddening• blisters• rash• 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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
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.• if you have ever had an allergic reaction to this product or any of its ingredients• with any other drug containing acetaminophen (prescription or nonprescription). Ifyou 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.• if you have ever had an allergic reaction to this product or any of its ingredients
Ask 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 such as emphysema or chronic bronchitis• trouble urinating due to an enlarged prostate gland• persistent or chronic cough as occurs with smoking, asthma, or emphysema• a sodium-restricted diet• liver disease• heart disease• thyroid disease• diabetes• high blood pressure• trouble urinating due to an enlarged prostate gland• cough that occurs with too much phlegm (mucus)• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
• taking sedatives or tranquilizers• taking the blood thinning drug warfarin
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
do not use more than directed
Stop Use And Ask A Doctor If
• you get nervous, dizzy or sleepless• 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 headache that lasts. These could be signs of a serious condition.• 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.
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.
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• take only as directed – see Overdose warning• 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 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
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 | ask a doctor |
children under 4 yrs | do not use |
Other Information
• each 30 mL contains: sodium 44 mg• store at 20-25°C (68-77°F)• each 15 mL contains: sodium 6 mg• store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
alcohol, anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C green #3, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose
butylated hydroxyanisole, edetate disodium, FD&C yellow #6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum
Questions Or Comments?
1-800-719-9260
1-800-719-9260
Daytime Severe Cold & Fluactive Ingredients – (In Each 15 Ml)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Package/Label Principal Display Panel
COMBO PACK
SEE NEW WARNINGS
Compare to the active ingredients of Vicks® DayQuil® Severe Cold & Flu and Vicks® NyQuil® Severe Cold & Flu
MAXIMUM STRENGTH
daytime
severe
cold & flu relief
acetaminophen
phenylephrine HCl
dextromethorphan HBr
guaifenesin
pain reliever/fever reducer
nasal decongestant
cough suppressant
expectorant
NON-DROWSY
ALCOHOL FREE
ANTIHISTAMINE FREE
multi-symptom relief
12 FL OZ (355 mL)
MAXIMUM STRENGTH
nighttime
severe
cold & flu relief
acetaminophen
dextromethorphan HBr
doxylamine succinate
phenylephrine HCl
pain reliever/fever reducer
nasal decongestant
cough suppressant
antihistamine
multi-symptom relief
10% ALCOHOL
12 FL OZ (355 mL)
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