FDA Label for Bionatuss Dxp
View Indications, Usage & Precautions
Bionatuss Dxp 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
Dexbrompheniramine Maleate.............2mg................................Antihistamine
Dextromethorphan HBr..................20mg.................................Cough Suppressant
Phenylephrine HCL......................10mg................................. Nasal Descongestant
Otc - Purpose
Uses
Temporarily relieves cough due to minor throat and bronchialirritations as may occur with the common cold !"temporarily relieves nasal
congestions due to the common cold"!"for temporary relief of runny nose,
sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever
or allergic rhinitis.
Warnings
Warnings:
When using this product, do not exceed recommended dosage.Stop use and ask a doctor if
- your child gets nervous, dizzy or sleepless
- condition lasts for more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
Warning: Phenylketonuric: Contains 6.25 mg of Phenylalanine per 5mL (one teaspoonful) dose.
Otc - Do Not Use
Do not use in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. May cause
excitability especially in children. Do not take this product, if you have a breathing problem such as emphysema or
chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland, heart disease,
high blood pressure, diabetes or thyroid disease, unless directed by a doctor. May cause drowsiness; alcohol,
sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product.
Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution
when driving a motor vehicle or operating machinery.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help orcontact 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 or
as directed by a doctor.
| Adults and children 12 years of age and over | take 1 teaspoonful (5 mL) every 4 hours |
| Children 6 to under 12 years of age | take 1/2 teaspoonful (2.5 mL) every 4 hours |
| Children under 6 years of age | ask a doctor |
Indications & Usage
Other informationStore at room temperature 15- 30 degree Celsius (59 - 86 degree Farenheit). Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering. Alcohol Free and Phenylpropanolamine (PPA) Free.
Inactive Ingredient
Inactive ingredients: Ammonium glycyrrhizinate, aspartame, D and C Red #33, flavor, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water and sucrose.
Otc - Questions
Questions or comments? 1-305-403-3788
* Please review the disclaimer below.