Otc - Active Ingredient
Drug Facts
Active ingredients
(in each 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
The following Structured Product Label (SPL) was submitted to the FDA by Camber Consumer Care for the product Day Time High Blood Pressure Cold And Flu (NDC 69230-331). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active ingredients
(in each 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Purpose
Acetaminophen .................Pain reliever/Fever reducer
Dextromethorphan HBr ..........Cough suppressant
Uses
Temporarily relieves common cold/flu symptoms:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
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.
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.
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
Ask a doctor or pharmacist before use if you are taking the blood thinning drug Warfarin
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.
ask a health professional before use.
Keep out of reach of children.
| 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 information
• sodium content per tablespoon: 23 mg
• store at room temperature
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.
Questions? Call weekdays 1-888-588-1418
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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.