Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nuvicare NightTime Cold and Flu Softgel
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
INDICATIONS & USAGE SECTION
Uses:
temporarily relieves these common cold/flu symptoms:
■ minor aches & pains
■ headache
■ sore throat
■ fever
■ Runny nose and sneezing
■ cough due to minor throat & bronchial irritation
DOSAGE & ADMINISTRATION SECTION
Directions
■ take only as directed- see** OVERDOSE WARNING**
■ do not exceed 8 softgels per 24 hrs.
■ take softgels with water
|
Adults and children age 12 yrs and over |
2 softgels every 6 hrs. |
|
Children 4 to under 12 yrs |
ask a doctor |
|
Children under 4 yrs |
do not use |
WARNINGS SECTION
Warning
**Liver warning:**This product contains acetaminophen. Severe liver damage
may occur if you take:
■ more than 8 softgels in 24 hours, which is the maximum daily amount for this
product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic
drinks everyday while using this product.
**Allergy Alert:**acetamenophen may cause severe skin recations. Symptoms may include:
**■**skin reddening ■ blisters ■ rash. if a skin reactions 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.
OVERDOSAGE SECTION
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. (1-800-222-1222)
STORAGE AND HANDLING SECTION
Other information
■ store between 15-30°C (59 to 86 °F)
■ avoid excessive heat
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each softgel)
Acetaminophen 325mg
Dextromethorphan HBr 15mg
Doxylamine succinate 6.25 mg
OTC - PURPOSE SECTION
Purpose
Acetaminophen 325mg.....................Pain reliever/fever reducer
Dextromethorphan HBr 15mg..................... Cough suppressant
Doxylamine succinate 6.25 mg ............................. Antihistamine
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
■ liver disease
■ glaucoma
■ cough that occurs with too much phlegm (mucus)
■ a breathing problem or chronic cough that last or as occurs with smoking, asthma, chronic bronchitis, or emphysema
■ trouble urinating due to enlarged prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedative or tranquilizers.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OTC - DO NOT USE SECTION
Do not use:
- 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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
OTC - STOP USE SECTION
Stop use and ask a doctor if
- pain or cough get worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
OTC - WHEN USING SECTION
When using this product
- do not exceed recommeded dosage.
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedative and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
OTC - QUESTIONS SECTION
Questions or Comments?
Call 1-718-337-8733 or email: support@nuvicare.com
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
SPL UNCLASSIFIED SECTION
Distributed by: Nuvicare LLC, Brooklyn, NY 11211, USA
INACTIVE INGREDIENT SECTION
Inactive ingredients
Polyethylene Glycol400, Propylene Glycol, Povidone (PVP K-30),Purified water, Gelatin, Glycerin, Sorbitol Sorbitan solution, FD & C Blue No. 1, D &C Yellow No.10