FDA Label for Cold And Flu Severe Nighttime
View Indications, Usage & Precautions
- OTHER
- 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
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 24 SOFTGEL BLISTER PACK CARTON
Cold And Flu Severe Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. 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
Otc - Purpose
Active ingredients (in each softgel) | Purposes |
---|---|
Acetaminophen 325 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 10 mg | Cough suppressant |
Doxylamine succinate 6.25 mg | Antihistamine |
Phenylephrine HCl 5 mg | 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 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 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.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- a sodium-restricted diet
- trouble urinating due to enlarged prostate gland
- 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
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.
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.
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take only as directed
- do not exceed 8 softgels per 24 hours
adults & children 12 yrs & over | 2 softgels with water every 4 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
Other Information
- store at 20-25°C (68-77°F)
- protect from light, heat and moisture
Inactive Ingredients
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone K30, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide
Questions?
Call toll free: 1-888-423-0139
Principal Display Panel - 24 Softgel Blister Pack Carton
NDC: 36800-827-24
*Compare to the active ingredients
in Vicks® Nyquil™ Severe Cold & Flu
MAXIMUM STRENGTH RELIEF
Night Time
Cold & Flu Relief
SEVERE
PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN
COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
ANTIHISTAMINE - DOXYLAMINE SUCCINATE
NASAL DECONGESTANT - PHENYLEPHRINE HCl
• Headache, Fever, Sore Throat, Minor Aches & Pains
• Sinus Congestion & Pressure
• Runny Nose & Sneezing • Cough
24 SOFTGELS
actual size
* Please review the disclaimer below.