nitetime severe
Publix Super Markets, Inc. Nitetime Severe Drug Facts
c5535aaf-c029-48d8-97d1-105a49b5fd95
HUMAN OTC DRUG LABEL
May 19, 2025
Publix Super Markets Inc
DUNS: 006922009
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (18)
Drug Labeling Information
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
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
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.
DOSAGE & ADMINISTRATION SECTION
Directions
•
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 |
STORAGE AND HANDLING SECTION
Other information
•
**each 30 mL contains:** sodium 41 mg
•
store at 68-77°F (20-25°C)
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