FDA Label for Daytime Nighttime Cold And Flu Relief Multi-symptom
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS IN DAYTIME (IN EACH SOFTGEL)
- ACTIVE INGREDIENTS IN NIGHTTIME (IN EACH SOFTGEL)
- PURPOSE FOR DAYTIME
- PURPOSE FOR NIGHTTIME
- USES
- WARNINGS
- 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
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Daytime Nighttime Cold And Flu Relief Multi-symptom Product Label
The following document was submitted to the FDA by the labeler of this product P & L Development, 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 In Daytime (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Active Ingredients In Nighttime (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Purpose For Daytime
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Purpose For Nighttime
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
DAYTIME
- temporarily relieves common cold and flu symptoms
- cough due to minor throat and bronchial irritation
- nasal condition
- headache
- minor aches and pains
- fever
- sore throat
- temporarily relieves common cold and flu symptoms
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
- runny nose & sneezing
NIGHTTIME
Warnings
DAYTIME NIGHTTIME
Liver warning: These products contain 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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
DAYTIME NIGHTTIME
- 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
DAYTIME
- liver disease
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occur with smoking, asthma, or emphysema
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to an enlarged prostate gland
NIGHTTIME
Ask A Doctor Or Pharmacist Before Use If You Are
DAYTIME
- taking the blood thinning drug warfarin.
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
NIGHTTIME
When Using This Product,
DAYTIME
do not use more than directed.
NIGHTTIME
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
DAYTIME
- nervousness, dizziness, or sleeplessness occur
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- redness or swelling is present
- new symptoms occur
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with rash or headache that lasts.
- pain 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.
NIGHTTIME
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.
DAYTIME NIGHTTIME
Overdose warning: Taking more than the recommended dose can cause liver damage. 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.
Directions
- do not take more than directed (see Overdose warning )
- do not take more than 4 doses in 24 hours
- swallow whole; do not crush, chew, or dissolve
- children under 12 years: do not use
Daytime: adults and children 12 years and over: take 2 softgels with water every 4 hours
Nighttime: adults and children 12 years and over: take 2 softgels with water every 6 hours
Other Information
- store between 15°-30°C (59°-86°F)
- avoid excessive heat
Inactive Ingredients
Daytime butylated hydroxyanisole, butylated hydroxytoluene, carminic acid*, D&C yellow #10*, edible white ink, FD&C red #40*, FD&C yellow #6*, gelatin, glycerin, polyethylene glycol*, povidone, propylene glycol, purified water, sodium metabisulfite*, sorbitan*, sorbitol
*may contain this ingredient
Nighttime D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan*, sorbitol
*may contain this ingredient
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
DAYTIME
daytime
Multi-Symptom Cold & Flu Relief
acetaminophen (pain reliever / fever reducer)
dextromethorphan HBr (cough suppressant)
phenylephrine HCl (nasal decongestant)
- non-drowsy
- alcohol-free
- antihistamine
- alcohol-free
softgels**
(**liquid-filled capsules)
NIGHTTIME
nighttime
multi-symptom cold & flu relief
acetaminophen (pain reliever / fever reducer)
dextromethorphan HBr (cough suppressant)
doxylamine succinate (antihistamine)
softgels
(**liquid-filled capsules)
When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing.
†Compare to the active ingredients in Vicks® DayQuil® and NyQuil® Cold & Flu LiquiCaps®
*This product is not manufactured or distributed by The Procter & Gamble Company, Vicks® DayQuil® and NyQuil® LiquiCaps® are registered trademarks of The Procter and Gamble Company.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Distributed by: PL Developments
200 Hicks Street, Westbury, NY 11590
Product Label
WELLNESS BASICS Daytime Nighttime Multi-Symptom Cold and Flu Relief
* Please review the disclaimer below.