Otc - Active Ingredient
Chlorpheniramine Maleate 4mg
Chlorpheniramine Maleate 4mg
FDA Label NDC 70692-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc for the product Chlorpheniramine Maleate 4mg (NDC 70692-113). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, otc - purpose, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
D&C yellow #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch
Dosage & Administration
- take with a full glass of water
- do not take more than directed
| adults and children 12 yers of age and over | 1 tablet every 4 to 6 hours, do not take more than 6 tablets in 24 hours |
| children 6 to under 12 years of age | 1/2 tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours |
| children under 6 years of age | ask a doctor |
Indications & Usage
temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies
- sneezing
- runny nose
- itchy, watery eyes
- itching of the nose or throat
Warnings
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostrate gland
- excitability may occur, especially in children
- drowsiness may occur
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating a machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Ask a doctor or a pharmacist before use if
you sre taking sedatives or tranquilzers
When using this product
If pregnant or breast-feeding,
ask a health professional before use
Keep out of reach of children
Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Otc - Purpose
Antihistamine
Other Safety Information
- store at room temperature between 20 °C - 25 °C (68 °F - 77 °F)
- protect from excessive heat and moisture
* Please review the disclaimer below.
