Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nitetime severe
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package/Label Principal Display Panel
Nitetime Severe
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCl
• Nighttime cold & flu relief
• Pain reliever
• Fever reducer
• Nasal decongestant
• Cough suppressant
• Antihistamine
• Max strength
p
Berry Flavor
Compare to Vicks® NyQuil® Severe active ingredients
12 FL OZ (355 mL)
INDICATIONS & USAGE SECTION
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
DOSAGE & ADMINISTRATION SECTION
Directions
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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 |
WARNINGS SECTION
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
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.
•
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
•
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 such as occurs with smoking, asthma, or emphysema
•
a sodium-restricted diet
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 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.
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.
STORAGE AND HANDLING SECTION
Other information
•
**each 30 mL contains:** sodium 41 mg
•
store at 68-77°F (20-25°C)
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCl 10 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
INACTIVE INGREDIENT SECTION
Inactive ingredients
anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum