PAIN RELIEVER FEVER REDUCER - acetaminophen,dextromethorphan hydrobromide,phenylephrine hydrochloride,chlorpheniramine maleate tablet, effervescent
Velocity Pharma
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Active Ingredient
(in each tablet)
Acetaminophen 250 mg
Chlorpheniramine Maleate 2mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
pain reliever/fever reducer
Antihistamine
Cough Suppressant
Nasal decongestant
Uses
Temporarily relieves these symptoms due to cold or flu:
- Minor aches and pains
- Headaches
- Cough
- Sore throat
- Runny nose
- Sneezing
- Nasal and sinus congestion
- Temporarily reduces fever
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 tablets in 24 hours which is maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat waring: If sore throat is sever, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly. Do not use to sedate children.
do not use:
- with any other drug containing acetaminophen (prescription or not prescription). 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
- Heart disease
- Thyroid disease
- Diabetes
- High blood pressure
- Glaucoma
- Cough with excessive phlegm (mucus)
- A breathing problem such as emphysema or chronic bronchitis
- Difficulty in urinating due to enlargement of prostate gland
- Persistent or chronic cough such as occurs with smoking, asthma or emphysema
- A sodium restricted diet
-
ask your doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin.
- taking sedative or tranquilizers
when using this product
- do not exceed recommended dosage
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedative 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
- pain, cough or nasal congestion 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 serious condition.
- Nervousness, dizziness, or sleeplessness occurs
-
If pregnant or breast-feeding, ask a health professional before use
Keep out of reach of children.
Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. 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.
Direction
-
do not take more than the recommended dose
-
Adults and children 12 years and over: 2 tablets fully dissolved in 4 oz of water every 4 hours, Do not exceed 8 tablets in 24 hours or as directed by a doctor
-
children under 12 years: do not use
Other Information
- phenylketonurics: contains phenylalanine 15 mg per tablet
- store at room temperature , avoid excessive heat.
-
Total sodium : 415 mg/tablet
-
Total potassium: 1mg /tablet
INACTIVE INGREDIENT
acesulfame potassium, aspartame, citric acid anhydrous, color ponceau 4r, isopropyl alcohol, mannitol, orange flavor, pvp k-30, Simethicone, sodium benzoate, sodium bicarbonate, sodium saccharin, tween 80.
QUESTIONS
Call toll free 1-855-314-1850
Distributed by Velocity Pharma Llc
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 76168-021-13 6 tablets