FDA Label for Premier Value Night Time Severe Cold And Cough Honey Lemon Infused With Chamomile And White Tea Flavors
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- INDICATIONS & USAGE
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INFORMATION FOR PATIENTS
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Premier Value Night Time Severe Cold And Cough Honey Lemon Infused With Chamomile And White Tea Flavors Product Label
The following document was submitted to the FDA by the labeler of this product Premier Value. 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
Diphenhydramine hydrochloride 25 mg ........Antihistamine/Cough suppressant
Phenylephrine hydrochloride 10 mg .................................Nasal decongestant
Otc - Purpose
Uses
- temporarily relieves these symptoms due to a cold:
- minor aches and pains - minor sore throat pain
- headache - nasal and sinus congestion
- runny nose - sneezing
- itchy nose and throat - itchy, watery eyes due to hay fever
- 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, which is the maximum daily amount - with other drugs containing acetaminophen - 3 or more alcoholic drinks every day while using this product
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.
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 - Do Not Use
Do not use
- In a child under 4 years of age
- If you are allergic to Acetaminophen
- with any other drug containing acetaminophen (prescription and non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on the skin
-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 a MAOI, ask a doctor or pharmacist before taking this product.
Otc - Ask Doctor
Ask a doctor before use if you have
- liver disease - heart disease - high blood pressure
- thyroid disease - diabetes - glaucoma
- 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.
- a sodium restricted diet.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers.
- Taking the blood thinning drug warfarin
Indications & Usage
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.
Otc - Stop Use
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 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.
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.
| Age | Dose |
| children under 4 years of age | do not use |
| children 4 to under 12 years of age | do not use unless directed by a doctor |
| adults and children 12 years of age and over | one packet |
- dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- 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 7 mg, sodium 46 mg
- phenylketonurics: each packet contains phenylalanine 13 mg
- store at controlled room temperature 20-25C (68-77F). Protect from heat and moisture.
Inactive Ingredient
Acesulfame potassium, anhydrous citric acid, aspartame, caramel, D and C Yello 10, maltodextrin, natural flavors, sodium citrate, starch and sugar.
Package Label.Principal Display Panel
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