FDA Label for Altipres Pediatric
View Indications, Usage & Precautions
Altipres Pediatric Product Label
The following document was submitted to the FDA by the labeler of this product Alternative Pharmacal 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
Dextromethorphan HBr ............... 5 mg ................ Cough Suppressant
Guaifenesin .............................. 75 mg ................ Expectorant
Phenylephrine HCl ..................... 2.5 mg ................... Nasal Decongestant
Otc - Purpose
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
Warnings
Warnings
Ask a doctor before use if your child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to the enlargement of the prostate gland
- a cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic as occurs with smoking, asthma, chronic bronchitis or emphysema
- your child gets nervous, dizzy or sleepless
- 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
When using this product, do not exceed recommended dosage
Stop use and ask doctor if
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 taking this product -Do not use- in a child under 2 years of age.
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.
Indications & Usage
Indications
- Temporarily relieves cough due to minor throat and bronchial irritation as may occur with common cold
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
- temporarily relieves nasal congestion due to the common cold
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 4 teaspoonfuls (20 mL) every 4 hours |
| children 6 to under 12 years of age | take 2 teaspoonful (10 mL) every 4 hours |
| children 2 years to under 6 years of age | take 1 teaspoonful (5 mL) every 4 hours |
| children under 2 years of age | ask a doctor |
Inactive Ingredient
Inactive ingredients citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose
Otc - Questions
Questions or comments? 1-305-403-3788
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