FDA Label for Day-time Night-time
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS FOR NIGHT-TIME (IN EACH SOFTGEL)
- ACTIVE INGREDIENTS FOR DAY-TIME (IN EACH SOFTGEL)
- PURPOSE FOR NIGHTTIME
- PURPOSE FOR DAYTIME
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USING 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,
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Day-time Night-time Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, 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.
Active Ingredients For Night-Time (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan Hydrobromide 15 mg
Doxylamine succinate 6.25 mg
Active Ingredients For Day-Time (In Each Softgel)
Acetaminophen 325 mg, USP
Dextromethorphan Hydrobromide 10 mg
Phenylephrine HCl 5 mg
Purpose For Nighttime
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Purpose For Daytime
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
- minor aches and pains
- sore throat pain
- fever
- headache
- muscular aches
- nasal congestion (Day-Time only)
- runny nose and sneezing (Night-Time only)
- cough due to minor throat and bronchial irritation(Night- Time only)
Warnings
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take
- more than 6 doses in 24 hours (Night-Time), which is the maximum daily amount
- more than 6 doses in 24 hours (Day-Time), which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using these products
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, rash, nausea, or vomiting, consult a doctor promptly.
Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms
Do Not Use
- with other drugs 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.
- to make a child sleep
Ask A Doctor Before Using If You Have
- liver disease
- heart disease
- asthma
- emphysema
- thyroid disease
- diabetes
- high blood pressure
- cough with excessive phlegm (mucus)
- breathing problems
- chronic bronchitis
- persistent or chronic cough
- cough associated with smoking
- trouble urinating due to enlarged prostate gland
- glaucoma (Night-Time only)
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, in addition when using Night-Time:
- 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 with other products containing acetaminophen
Stop Use And Ask A Doctor If
- swelling or redness is present
- symptoms do not get better within 7 days or are accompanied by a fever
- you get nervous, dizzy or sleepless
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache. These may be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health care professional before use.
Directions
- take only as recommended (see overdose warning)
- take Night-Time or Day-Time
- If taking Night-Time and Day-Time softgels limit total to 4 doses per day
age | Night-Time | Day-Time |
adults and children 12 years of age and older | swallow 2 softgels with water every 6 hours | swallow 2 softgels with water every 4 hours |
children 4 to 12 years of age | ask a doctor | ask a doctor |
children under 4 years of age | do not use | do not use |
Other Information
- store at room temperature 15°-30°C (59°-86° F) and avoid excessive heat
- this product does not contain phenylpropanolamine (PPA)
- *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Dayquil® and Vicks® Nyquil®
Inactive Ingredients
Night-Time D&C Yellow #10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol 400 NF, *polyethylene glycol (PEG)- 600, povidone, propylene glycol USP, purified water USP, sorbitan, sorbitol and white edible ink. *May also contain
Day-Time *butylated hydroxyanisole, *butylated hydroxytoluene, *carmine, *D&C yellow #10, FD&C Red#40, FD&C yellow #6, gelatin, glycerin USP, *mannitol, polyethylene glycol 400 NF, *polyethylene glycol 600, povidone, propylene glycol USP, purified water USP, *sodium metabisulfite, *sorbitan, *sorbitol, sorbitol special, and white edible ink. *May also contain.
Questions Or Comments?
call toll free 1-877-753-3935
Principal Display Panel
*Compare to active ingredients in Vicks® Dayquil® & Nyquil®
SEE NEW WARNINGS INFORMATION
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
DISTRIBUTED BY:
CHAIN DRUG CONSORTIUM, LLC.
2300 NW CORPORATE BLVD., SUITE 115
BOCA RATON, FL 33431
Product Label
Multi symptom Day-Time Night-Time
* Please review the disclaimer below.