The following Structured Product Label (SPL) was submitted to the FDA by Quality Home Products for the product Western Family Nighttime Severe Cold And Cough (NDC 64525-0564). 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, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, indications & usage, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each packet) Purpose
Acetaminophen 650 mg ........................................Pain reliever/Fever reducer
Diphenhydramine hydrochloride 25 mg .........Anitihistamine/Cough suppressant
Phenylephrine hydrochloride 10 mg...................................Nasal decongestant.
Uses
- temporarily relieves:
- minor aches and pains - headache - minor sore throat pain
- nasal and sinus congestion - cough due to minor throat and bronchial irritation
- runny nose - sneezing - itchy, watery eyes due to hay fever
- itchy nose and throat
- temporarily reduces fever.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets in 24 hours, which is the maximum daily amount - 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 and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
- with any other product containing diphenhydramine, even one used on the skin
- If you are now taking a prescription monoamine oxidase (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 a MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease - heart disease - high blood pressure - thyroid disease - glaucoma - diabetes - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema, asthma, or chronic bronchitis - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema.
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin.
When using this product
- do not exceed recommended dosage
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children.
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- symptoms do not get better or worsen
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed
- take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor.
- adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- children under 12 years of age: consult a doctor.
- if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.
Other information
- each packet contains: potassium 7 mg, sodium 46 mg
- phenylketonurics: contains phenylalanine 13 mg per packet
- store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture.
Acesulfame K, Aspartame, Caramel Color, Citric Acid, D and C Yellow 10, Maltodextrin, Natural Flavors, Sodium Citrate, Starch and Sugar.
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