Active Ingredients (In Each 15 Ml) Daytime
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Daytime Nighttime Severe Cold And Flu Relief Kit
FDA Label NDC 55319-138
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar (family Wellness) for the product Daytime Nighttime Severe Cold And Flu Relief (NDC 55319-138). 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 active ingredients (in each 15 ml) daytime, active ingredients for (in each 30 ml) nighttime, purposes for daytime, purpose for nighttime, uses, warnings, do not use, ask a doctor before use if the user has, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients For (In Each 30 Ml) Nighttime
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine Succinate 12.5 mg
Phenylephrine HCI 10 mg
Purposes For Daytime
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Purpose For Nighttime
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
DAYTIME
- temporarily relieves common cold and flu symptoms
- nasal congestion
- sinus congestion and pressure
- minor aches and pains
- headache
- fever
- sore throat
- reduces swelling of nasal passages
- cough due to minor throat and bronchial irritation
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves these common cold/flu symptoms
- nasal congestion
- sore throat
- headache
- sinus congestion and pressure
- minor aches and pains
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
- temporarily reduces
- fever
- cough to help you sleep
- swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
NIGHTTIME
Warnings
DAYTIME
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
- child takes more than 4 doses (15 mL each) in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash.
- 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.
NIGHTTIME
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.
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 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask A Doctor Before Use If The User Has
DAYTIME
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- a sodium-restricted diet
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- glaucoma
- a sodium-restricted diet
- 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
NIGHTTIME
Ask A Doctor Or Pharmacist Before Use If You Are
DAYTIME
taking the blood thinning drug warfarin.
NIGHTTIME
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product
DAYTIME
do not take more than directed
NIGHTTIME
- do not take 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
Stop Use And Ask A Doctor If
DAYTIME
- nervousness, dizziness or sleeplessness occur
- pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult)
- 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.
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion, 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 (overdose) may couse liver damage. 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.
Directions
DAYTIME
- take only as directed (see Overdose warning)
- do not take more than 4 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL= milliliter
- take only as directed (see Overdose warning)
- Do not exceed 4 doses per 24 hours
- measure only with dosing cup provided. Do not use any other dosing device.
- mL= milliliter
- keep dosing cup with product
- adults and children 12 years and over: 30 mL every 4 hours
- children under 12 years of age: do not use
- when using other Daytime or Nighttime products, carefully read each label or ensure correct dosing
| adults and children 12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children 4 to under 6 years | ask a doctor |
| children under 4 years | do not use |
NIGHTTIME
Other Information
DAYTIME
- each 15 mL contains: sodium 12 mg
- store between 20-25°C (68-77°). Do not refrigerate
- each 30 mL contains: sodium 64 mg
- store between 20-25°C (68-77°F). Do not refrigerate
NIGHTTIME
Inactive Ingredients
DayTime
citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride,sodium citrate, sorbitol, sucralose, xantham gum
NightTime
anhydrous citric acid, FD&C blue #1, Fd&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, trisodium citrate dehydrate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to the active ingredients of Vicks® DayQuil® and NyQuil® Severe Cold & Flu
DAYTIME
Severe Daytime
Cold & Flu Relief
Acetaminophen 325 mg
Pain reliever / Fever reducer
Dextromethorphan HBr 10 mg
Cough suppressant
Guaifenesin 200 mg
Expectorant
Phenylephrine HCI 5 mg
Nasal decongestant
Relieves
- Headache, fever, sore throat, minor aches & pains
- Nasal/sinus congestion & sinus pressure
- Cough
- Chest congestion
- Headache, fever, sore throat, minor aches & pains
- Nasal/sinus congestion & sinus pressure
- Sneezing
- Runny nose
- Cough
For ages 6 years and over
Max strength
Alcohol free
Non-drowsy
NIGHTTIME
Severe Nighttime
Cold & Flu Relief
Acetaminophen 650 mg
Pain reliever / Fever reducer
Dextromethorphan HBr 20 mg
Cough suppressant
Doxylamine succinate 12.5 mg
Antihistamine
Phenylephrine HCI 10 mg
Nasal decongestant
Relieves
Max strength
Alcohol free
FL OZ (mL)
BERRY FLAVOR
When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil® and NyQuil® are registered trademarks of The Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
500 VOLVO PKWY, CHESAPEAKE, VA 23320
Product Label
FAMILY WELLNESS Severe Daytime and Nighttime Cold and Flu Relief
* Please review the disclaimer below.
