The following Structured Product Label (SPL) was submitted to the FDA by Quality Home Products for the product Quality Choice Day Time Severe Cold And Cough (NDC 64525-0549). 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 - ask doctor, otc - do not use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, 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
Dextromethorphan hydrobromide 20 mg ..............Cough suppresant
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
-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
-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.
Ask a doctor before us if you have
-liver disease -heart disease -high blood pressure
-thyroid disease -diabetes -trouble urinating due to an enlarged prostate gland
-cough that occurs with too much phlegm (mucus)
-cough that lasts or is chronic such as occurs with smoking, asthma or emphysema.
As a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
When using this product
-do not exceed recommended dosage
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 care 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 8 mg, sodium 20 mg
-phenylketonurics: contains phenylalanine 14 mg per packet
-store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture.
Image Of Carton Label (Qualitychoicedaytimecartonlabel)
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