FDA Label for Day Time High Blood Pressure Cold And Flu
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- IF PREGNANT OR BREAST-FEEDING,
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL: DAYTIME COLD & FLU HIGH BLOOD PRESSURE
Day Time High Blood Pressure Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Camber Consumer Care. 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.
Otc - Active Ingredient
Drug Facts
Active ingredients
(in each 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Otc - Purpose
Purpose
Acetaminophen .................Pain reliever/Fever reducer
Dextromethorphan HBr ..........Cough suppressant
Indications & Usage
Uses
Temporarily relieves common cold/flu symptoms:
- 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 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
- skin reddening
- blisters
- rash
Allery 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.
Otc - Do Not Use
Do not use: • with any other drug containing acetaminophen (prescription or non-prescription). 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 two 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 •cough that occurs with too much phlegm (mucus) • persistent or
chronic cough such as occurs with smoking, asthma or emphysema
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug Warfarin
Otc - Stop Use
Stop use and ask a doctor if
• pain or cough gets worse or last 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
- take only as directed
- only use dose cup provided
- do not take more than 4 doses per 24 hours
adults and children 12 years and over | 30 mL every 4 hours |
children 4 to under 12 years | ask a doctor |
children under 4 years | do not use |
Other Safety Information
Other information
• sodium content per tablespoon: 23 mg
• store at room temperature
Inactive Ingredient
Inactive ingredients
citric acid, FD&C Yellow no. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate,
sodium citrate, sorbitol, sucralose, xanthan gum.
Otc - Questions
Questions? Call weekdays 1-888-588-1418
Package Label: Daytime Cold & Flu High Blood Pressure
------------------------
DAYTIME Cold & Flu High Blood Pressure
8 FL OZ (237 mL)
* This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark Vicks®
DayQuil® High Blood Pressure Cold & Flu®.
Distributed by: Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA
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* Please review the disclaimer below.