FDA Label for Geri Care Tussin Cf Max
View Indications, Usage & Precautions
Geri Care Tussin Cf Max Product Label
The following document was submitted to the FDA by the labeler of this product Geri-care Pharmaceutical Corp. 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 20 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Cough Suppressant
Expectorant
Indications & Usage
Uses
- temporarily relieves these symptoms occurring with a cold or flu:
- cough due to minor throat and bronchial irritation
- minor aches and pains
- sore throat
- headache
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tunes and make coughs more productive
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 doses in any 24-hour period, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
- 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
- with any other drug containing acetaminophen (prescription or nonprescritpion), if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- liver disease
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- taking the blood thinning drug warfarin
- taking any other pain reliever/fever reducer
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more tha 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headhache that lasts
Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include
If 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.
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
Stop use and ask a doctor if
These could 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.
Dosage & Administration
Directions
- mL = mililiter
- do not take more tha 6 doses in any 24-hour period
- do not exceed recommended dosage. Taking more than the recommeded dose (overdose) may cause serious liver damage
- measure only with dosing cup provided
- keep dosing cup with product
- adults and children 12 years and over: 20 mL every 4 hours
- children under 12 years of age: do not use
Inactive Ingredient
Inactive ingredients: artificial and natural flavor, citric acid, FD&C #40, hyroxyethyl cellulose, menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
Otc - Questions
Questions or comments: 1-800-540-3765
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