FDA Label for Cold And Flu Day Time Multi-symptom Relief
View Indications, Usage & Precautions
- OTHER
- 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
- OVERDOSAGE
- KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL
Cold And Flu Day Time Multi-symptom Relief Product Label
The following document was submitted to the FDA by the labeler of this product Pharmacy Value Alliance, 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.
Other
Drug Facts
Otc - Active Ingredient
Active Ingredients
(in each 15mL, 1tablespoon)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5mg
Otc - Purpose
Purpose
Acetaminophen Pain reliever/fever reducer
Dextromethorphan HBr Cough suppressant
Phenylephrine HCI Nasal decongestant
Indications & Usage
Uses temporarily relieves these common cold/flu symptoms:
• minor aches and pains • headache • sore throat • fever
• nasal congestion • cough due to minor throat and bronchial irritation
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver
damage may occur if adult/child takes:
• more than 4doses in 24 hours, which is the maximum daily amount
for this product • with other drugs containing acetaminophen
• 3or more alcoholic drinks everyday 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
2days, is accompanied or followed by fever, headache, rash, nausea,
or vomiting, consult a doctor promptly.
Otc - Do Not Use
Do not use • 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 two weeks after stopping the
MAOI drug. If you do not know if your prescription drug contains an
MAOI, ask a doctor or a pharmacist before taking this product.
• with any other drug containing acetaminophen (prescription or
non-prescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacists.
Otc - Ask Doctor
Ask a doctor before use if you have
• liver disease • heart disease • thyroid disease • diabetes
• high blood pressure • trouble urinating due to enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma,
or emphysema • cough accompanied by excessive phlegm (mucus)
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the user is taking the
blood thinning drug warfarin
Otc - When Using
When using this product • do not use more than directed (see
overdose warning) • avoid alcoholic drinks
Otc - Stop Use
Stop use and ask a doctor if • you get nervous, dizzy or sleepless
• new symptoms occur • fever gets worse or lasts more than 3days
• pain or cough gets worse or lasts more than 5days (children) or
7days (adults) • redness or swelling is present
• 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. Keep this and all drugs out of the reach of children.
Overdosage
Overdose Warning: Taking more than the recommended dose
(overdose) could cause serious health problems, including liver
damage. In case of accidental overdose, seek professional
assistance or contact a Poison Control Center immediately.
Quick medical attention is critical for adults as well as for
children even if you do not notice any signs or symptoms.
Keep This And All Drugs Out Of The Reach Of Children.
Keep this and all drugs out of the reach of children.
Dosage & Administration
Directions
• take only as recommended (see overdose warning) • use dosage
cup or tablespoon (TBSP) • do not exceed 4doses per 24 hours
age dose
adults and children 30 mL (2 TBSP)
12 years and over every 4hours
children 6 to 15 mL (1 TBSP)
under 12 years every 4 hours
children 4 years to ask a doctor
under 6 years
children under 4 years do not use
• When using Day Time and Night Time products, carefully
read each label to ensure correct dosing.
Other Safety Information
Other information
• sodium content per tablespoon: 10 mg
• store at room temperature
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences
Inactive Ingredient
Inactive ingredients
citric acid, FD&C Yellow #6, flavor, glycerin, propylene glycol
purified water, saccharin sodium, sodium benzoate, sucrose
Otc - Questions
Questions?Call weekdays 1-877-798-5944.
*This product is not manufactured or distributed by Proctor &
Gamble, owner of the registered trademark Vicks® NyQuil®.
DISTRIBUTED BY: PHARMACY VALUE ALLIANCE, LLC
407 EAST LANCASTER AVENUE, WAYNE PA 19087
If for any reason you are not satisfied with this product, please
return It to the store where purchased for a full refund.
Principal Display Panel
Premier® Value
COMPARE TO THE ACTIVE
INGREDIENTS IN
VICKS® DAYQUIL®*
COLD & FLU
Day Time Multi-Symptom Relief
Acetaminophen...... Pain Reliever/Fever Reducer
Dextromethorphan Hsr...... Cough Suppressant
Phenylephrine HCI........Nasal Decongestant
Non-drowsy
8 FL OZ (237 mL)
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences
Questions? Call weekdays 1-877-798-5944.
*This product is not manufactured or distributed by Proctor &
Gamble, owner of the registered trademark Vicks® NyQuil®.
DISTRIBUTED BY: PHARMACY VALUE ALLIANCE, LLC
407 EAST LANCASTER AVENUE, WAYNE PA 19087
If for any reason you are not satisfied with this product, please
return It to the store where purchased for a full refund.
LR-028
REV-01
Product Label - 8 FL OZ
Product Label - 12 FL OZ
Premier Value Cold & Flu Day Time Multi-Symptom Relief
* Please review the disclaimer below.