FDA Label for Daytime Cold And Flu Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH SOFTGEL)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT,
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Daytime Cold And Flu Relief Product Label
The following document was submitted to the FDA by the labeler of this product Salado Sales Inc.. 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.
Active Ingredients (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
■ nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 liquid caps 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
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 (MAOl) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOl drug. If you do not know if your prescription drug contains an MAOl, ask a doctor or pharmacist before taking this product.
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
■ cough that occurs with too much phlegm (mucus)
■ persistent or chronic cough as occurs
with smoking, asthma or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
When Using This Product,
do not use more than directed
Stop Use And Ask A Doctor If
■you get nervous, dizzy or sleepless
■ symptoms get worse or last more than 5 days (children) or 7
days (adults)
■ fever gets worse or lasts more lhan 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Quick medical attention is critical for adults as well as children, even if you do not notice any signs or symptoms.
Directions
- take only as directed (see Warnings)
- do not exceed 4 doses per 24 hrs
| adults & children 12 yrs & over | 2 softgels with water every 4 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
■ when using other Daytime or Nighttime products,
carefully read each label to ensure correct dosing
Other Information
- Store at room temperature 20-25°C(68-77°F)
- avoid excessive heat
Inactive Ingredients
FD&C Red#40, FD&C yellow#06,
gelatin, Glycerin, Polyethylene glyccl, Povidone, Propylene glycol,
Purified water, Sorbitol sorbitan solution, Titanium dioxide.
Questions?
Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
Package Label.Principal Display Panel
CVP COMPARE TO VICKS® DAYQUIL™
HEALTH COLD & FLU LIQUICAPS™
DAY TIME ACTIVE INGREDIENTS
SOFTGELS
MULTI-SYMPTOM COLD & FLU MEDICINE
• ACETAMINOPHEN-PAIN RELIEVER/FEVER REDUCER
• DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT
• PHENYLEPHRINE HCl - NASAL DECONGESTANT
24 SOFTGELS
Distributed by Consumer Value Products, Inc.
P.O. Box 6115, Temple, Texas 76502
CVPproducts.com
*This product is not manufactured or distributed by Procter &
Gamble, owner of the registered trademark Vicks® DayQuil™
LiquiCaps™
RES
* Please review the disclaimer below.
