FDA Label for Walgreen High Blood Pressure Nighttime Cold And Flu
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- LIVER WARNING
- SORE THROAT WARNING
- 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
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 236 ML BOTTLE LABEL
Walgreen High Blood Pressure Nighttime Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens Co.. 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
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
Distributed by
Otc - Purpose
| Active ingredients (in each 30 mL dose cup) | Purpose |
|---|---|
Acetaminophen 650 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 30 mg | Cough suppressant |
Doxylamine succinate 12.5 mg | Antihistamine |
Uses
temporarily relieves common cold/flu symptoms:
▪ cough due to minor throat and bronchial irritation▪ sore throat▪ headache▪ minor aches and pains▪ fever▪ runny nose and sneezing
Liver Warning
This product contains acetaminophen.
Severe liver damage may occur if you take
▪ more than 4 doses (30 mL each dose) in 24 hours, which is the maximum daily amount for this product▪ with other drugs containing acetaminophen▪ 3 or more alcoholic drinks every day while using this product
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 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 (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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
▪ liver disease▪ glaucoma▪ 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
Ask A Doctor Or Pharmacist Before Use If You Are
▪ taking sedatives or tranquilizers▪ taking the blood thinning drug warfarin
When Using This Product
▪ 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
▪ pain 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
▪ take only as directed▪ use dose cup provided▪ do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over | 30 mL per dose every 6 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
Other Information
• each 30 mL contains: sodium16 mg• store at room temperature
Inactive Ingredients
Anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose
Questions?
1-866-467-2748
Principal Display Panel - 236 Ml Bottle Label
Compare to the active ingredients in Vicks® NyQuil™ High Blood Pressure Cold & Flu*
NDC 0363-6210-08
High Blood
Pressure
Nighttime
Cold & Flu
Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr
Headache, Fever, Sore Throat,
Minor Aches & Pains
Sneezing, Runny Nose
Cough
Sugar Free & No Added Alcohol
8 FL OZ (236 mL)
*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® NyQuil™ High Blood Pressure Cold & Flu.
* Please review the disclaimer below.