ONESSIP ADULT DAYTIME SEVERE COLD AND FLU
- Manufacturer
- MEDWISE LIFESCIENCES INC.
- Effective date
- 2025-12-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:23:37
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OneSsip Day Time Adult Severe Cold & Flu 15 mL Sachet Drug Facts
Active ingredients (in each 15 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
INDICATIONS & USAGE SECTION
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
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
WARNINGS SECTION
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
- child 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:
- 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.
OTC - DO NOT USE SECTION
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 SECTION
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, chronic bronchitis, or emphysema
- a sodium-restricted diet
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
OTC - WHEN USING SECTION
When using this product, do not use more than directed.
OTC - STOP USE SECTION
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 SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 SECTION
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 SECTION
Inactive ingredients
citric acid anhydrous, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum, stevia powder, menthol, sodium edetate.
OTC - QUESTIONS SECTION
Question or comments?
call 1-516-675-8915
RECENT MAJOR CHANGES SECTION
Change of section type "Indiacation and Usage Section" from "Instruction to Usage Section"
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 87078-972-03 | ONESSIP ADULT DAYTIME SEVERE COLD AND FLU | 15 mL in 1 POUCH | SOLUTION | 15 | 1 | |
| 87078-972-32 | ONESSIP ADULT DAYTIME SEVERE COLD AND FLU | 12 in 1 CARTON | SOLUTION | 12 | 1 |
Products#
Every source-derived product name is available through these pages.
- ONESSIP ADULT DAYTIME SEVERE COLD AND FLU
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- EDETATE DISODIUM
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ACETAMINOPHEN
- GLYCERIN
- PROPYLENE GLYCOL
- GUAIFENESIN
- SORBITOL SOLUTION
- MENTHOL, UNSPECIFIED FORM
- ANHYDROUS CITRIC ACID
- SODIUM SACCHARIN
- SODIUM BENZOATE
- XANTHAN GUM
- FD&C YELLOW NO. 6
- WATER
- SODIUM CITRATE
- SUCRALOSE
- STEVIA LEAF
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 87078-972 | 87078-972-03, 87078-972-32 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ONESSIP ADULT DAYTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | MEDWISE LIFESCIENCES INC. | 45fa9159-d74c-063a-e063-6294a90a3ed0 | 2025-12-15 | Warnings | 87078-972-32 87078-972-03 87078-972 87078097203 87078097232 45fa9159-d74d-063a-e063-6294a90a3ed0 45fa9159-d74c-063a-e063-6294a90a3ed0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
