Label: CHLORPHENIRAMINE MALEATE - chlorpheniramine maleate tablet, film coated, extended release
- NDC Code(s): 37205-117-62
- Packager: Cardinal Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Chlorpheniramine maleate 12 mg
temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:Close
itchy, watery eyes
itching of the nose or throat
Ask a doctor before use if you haveClose
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
When using this product
excitability may occur, especially in children
drowsiness may occur
avoid alcoholic beverages
alchohol, sedatives and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088
If pregnant or breast-feeding, ask a health professional before use
- KEEP OUT OF REACH OF CHILDREN
In case of overdose, get medical help or contact a Poison Control Center right away.Close
adults and children 12 years and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
children under 12 years of age: ask a doctor
- OTHER INFORMATION
each tablet contains: calcium 28 mg
store between 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F)
protect from excessive moisture
- INACTIVE INGREDIENTS
calcium sulfate, carnauba wax, colloidal silicon dioxide, confectioner’s sugar, D&C yellow No. 10 aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake, FD&C yellow No. 6, gelatin, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, methyl parahydroxybenzoate, microcrystalline cellulose, pharmaceutical ink, polysorbate 80, povidone, propyl parahydroxybenzoate, propylene glycol, sodium benzoate, sodium lauryl sulphate, sucrose, talc, titanium dioxide, triethyl citrate
Chlorpheniramine maleate 12 mg is used as an antihistamine.
Newtown, PA 18940
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Chlorpheniramine maleate 12 mg
- INGREDIENTS AND APPEARANCE
chlorpheniramine maleate tablet, film coated, extended release
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-117 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 12 mg Inactive Ingredients Ingredient Name Strength CALCIUM SULFATE CARNAUBA WAX SILICON DIOXIDE SUCROSE D&C YELLOW NO. 10 FD&C BLUE NO. 2 GELATIN HYDROXYPROPYL CELLULOSE LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A METHYLPARABEN CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 POVIDONE PROPYLENE GLYCOL SODIUM BENZOATE SODIUM LAURETH SULFATE TITANIUM DIOXIDE TRIETHYL CITRATE FD&C YELLOW NO. 6 TALC Product Characteristics Color BROWN Score no score Shape ROUND Size 7mm Flavor Imprint Code Allergy;12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-117-62 24 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040829 12/20/2010 Labeler - Cardinal Health, Inc. (097537435) Registrant - KVK-Tech, Inc. (173360061) Establishment Name Address ID/FEI Business Operations KVK-Tech, Inc. 173360061 MANUFACTURE(37205-117)