FDA Label for Premier Value Day Time Severe Cold And Cough Berry Infused With Menthol And Green Tea Flavors
View Indications, Usage & Precautions
Premier Value Day Time Severe Cold And Cough Berry Infused With Menthol And Green Tea Flavors Product Label
The following document was submitted to the FDA by the labeler of this product Quality Home Products. 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
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
Otc - Purpose
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
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.
Otc - Ask Doctor
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.
Otc - Do Not Use
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health care professional before use.
Otc - Keep Out Of Reach Of Children
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.
Dosage & Administration
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.
Information For Patients
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.
Package Label.Principal Display Panel
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