FDA Label for Daytime Cold And Flu And Nigttime Cold And Flu
View Indications, Usage & Precautions
- DRUG FACTS
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- OTHER SAFETY INFORMATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Daytime Cold And Flu And Nigttime Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Better Living Brands 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.
Drug Facts
Daytime Cold & Flu
Nighttime Cold & Flu
Otc - Active Ingredient
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylphrine HCl 5 mg
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Otc - Purpose
Purpose
Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant
Purpose
Pain reliever/Fever reducer
Cough suppressant
Antihistamine
Indications & Usage
Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
- runny nose & sneezing
Uses
temporarily relieves common cold/flu symptoms:
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
- skin reddening
- blisters
- rash
- more than 4 doses in 24 hrs, 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
- 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.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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.
Otc - Do Not Use
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.
- 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.
Do not use
Otc - Ask Doctor
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- liver disease
- glaucoma
- 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
- trouble urinating due to enlarged prostate gland
Ask a doctor before use if you have
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if youare taking the blood thinning drug warfarin.
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
Otc - When Using
When using this product, do not use more than directed.
When using this product
- 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, & tranquilizers may increase drowsiness
Otc - Stop Use
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough get 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.
- 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.
Stop use and ask a doctor if
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
take only as directed
do not exceed 4 doses per 24 hours
- adults & children 12 yrs & over: 2 softgels with water every 4 hours
- children 4 to under 12 yrs: ask a doctor
- children under 4 yrs: do not use
- take only as directed
- do not exceed 4 doses per 24 hours
Directions
adults & children 12 yrs & over | 2 softgels with water every 6 hours |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
Storage And Handling
Other information
- store at room temperature
Inactive Ingredient
Inactive ingredients FD&C Red#40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.
Inactive ingredients D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.
Otc - Questions
Questions?1-877-290-4008
Questions? 1-877-290-4008
Other Safety Information
Other information
- store at room temperature
Package Label.Principal Display Panel
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