FDA Label for Bio T Pres-b
View Indications, Usage & Precautions
Bio T Pres-b Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Generic Corporation. 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 5 mL tsp) Purpose
Brompheniramine maleate 1 mg Antihistamine
Dextromethorphan HBr 5 mg Cough Suppressant
Phenylephrine HCl 2.5 mg Nasal Decongestant
Otc - Purpose
Uses
- temporarily relieves symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itchy nose or throat
- runny nose
- itchy, water eyes
- nasal congestion
- temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants
- temporarily restores freer breathing through nose
Warnings
Warnings
Do not use 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. Do not use on a child under 2 years of age.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- glaucoma
- diabetes
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or a pharmacist before
- giving this product to children who are taking sedatives or tranquilizers
- if you are taking sedatives or tranquilizers
Otc - Do Not Use
Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor.
When using this product
- do not use more than directed
- may cause drowsiness
- avoid alcoholic drink
- alcohol, sedatives and tranquilizers may increase drowsiness effect
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children Stop use and ask a doctor if
- you get nervous, dizzy or sleeplessness
- symptoms do not get better within 7 days or are accompanied by fever
- cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use.
Dosage & Administration
Directions Do not exceed more than 6 doses in any 24-hour period.
| adults and children 12 years of age and over | take 1 teaspoonfuls (5 mL) every 4 hours |
| children 6 to under 12 years of age | take 1/2 teaspoonfuls (2.5mL) every 4 hours |
| children 2 years to under 6 years of age | ask a doctor |
| children under 2 years of age | do not use |
Indications & Usage
Other Information
- Store between 15-30 degrees C (59-89 degrees F)
- Tamper evident feature: Do not use if cap seal is broken or missing
Inactive Ingredient
Inactive Ingredients
Water, citric acid, methylparaben, glycerin, propylene glycol, propylparaben, sodium citrate, flavor, sucralose
Otc - Questions
Questions or comments: 1-305-403-3788
Advanced Generic Corporation, Miami, Fl 33166
www.advancedgeneric.com
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