Onessip Night Time Adult Severe Cold & Flu 15 Ml Sachet Drug Facts
Active ingredients (in each 15 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine Succinate 12.5 mg
Phenylephrine HCl 10 mg
Onessip Adult Nighttime Severe Cold And Flu Solution
FDA Label NDC 87078-872
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medwise Lifesciences Inc. for the product Onessip Adult Nighttime Severe Cold And Flu (NDC 87078-872). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding onessip night time adult severe cold & flu 15 ml sachet drug facts, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Indications & Usage
Uses
- temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat & bronchial irritation
- 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
Warnings
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Allergy Alert:
Acetaminophen may cause severe skin reactions.
Symptoms may include:
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.
Otc - Ask Doctor
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- 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, chronic bronchitis, or emphysema
- a sodium-restricted diet
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin.
- taking sedatives or tranquilizer
Otc - When Using
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
Otc - Stop Use
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- 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.
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.
Dosage & Administration
Directions
- mL = milliliter
- take only as directed
- do not exceed 4 doses (4 Sachets) per 24 hours
- follow the instruction given on this carton for your easy use
Age (Years) | Dose (mL) |
adults & children 12 yrs & over | 15 mL (1 Sachet) every 4 hours |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
Other Safety Information
Other information
- store between 20-25°C (68-77°F)
- do not use if carton or sachet is torn, broken or punctured.
Inactive Ingredient
Inactive ingredients
citric acid anhydrous, FD&C Red No. 40, FD&C Blue No. 2, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum, stevia powder, menthol, sodium edetate.
Otc - Questions
Question or comments?
call 1-516-675-8915
Recent Major Changes
change
Package Label.Principal Display Panel
Ndc 87078-872-32 (Nyquil)
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