FDA Label for Palagrip
View Indications, Usage & Precautions
Palagrip Product Label
The following document was submitted to the FDA by the labeler of this product All Pharma, Llc. 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
Acvtive ingredients: (in 10 ml) Purpose
Acetaminophen 200 mg ............................. Analgesic
Dextromethorphan HBr 13.33 mg ................... Cough Suppressant
Guaifenesin 200 mg ................................... Expectorant
Phenylephrine HCl 5 mg ............................. Decongestant
Otc - Purpose
Purpose
Analgesic
Cough Suppressant
Expectorant
Decongestant
Indications & Usage
Uses
- For temporary relief of bronchial and nasal congestion
- Help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
- Teporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold
Warnings
Warnings
Do not exceed recommended dosage
Liver warning: This product contains Acetaminophen. Sever liver damage may occur if
- Adult takes more than 6 doses in 24 hours, which is the maximum daily amount
- Child takes more than 5 doses in 24 hours
- Taken with other drugs containing Acetaminophen
- Adult has 3 or more alcoholic drinks everyday while using this product
- Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician
Otc - Do Not Use
Do not use
- If you are now taking a prescription monoamine oxidase inhibitor (MAOI)( certain drugs for depression , psychiatric conditions, or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug.
- if you do not know if your prescription drug contains on MAOI ask your doctor or pharmacist before taking this product
- if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor
- avoid alcoholic beverages while you are taking this product
- do not use with any other drug containing Acetaminophen (prescirption or nonprescription). If you are not sure whether a drug contains Acetaminophen, ask a doctor or a pharmacist.
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
- heart disease, high blood pressure, thyroid disease, or difficulty in urination due to the enlargement of prostate gland.
- The user has liver disease
- The user is taking the blood thinning drug Warfarin.
Ask the doctor before use if you have
Otc - Stop Use
Stop use and ask the doctor if
- Nervoisness, dizziness or sleeplessness occurs.
- Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be sign of a serious condition
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health 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.
Dosage & Administration
Directions
- Do not take more than 6 doses in any 24-hour period
Age Dose
Adults and children 12 years and over 10 mL (2 tsps) every 6 hours
Children 6 to under 12 years of age. 5 mL (1 tsps) every 6 hours
Children under 6 years of age Do not use
Inactive Ingredient
Inactive ingredients
Aloe vera, citric acid, disodium EDTA, FD&C Red #40, hydroxyethyl cellulose, natural strawberry flavor, propylene glycol, water, sodium benzoate, sorbitol 70%, sucralose
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