Label: CHLORPHEN-12- chlorpheniramine maleate tablet, film coated, extended release
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NDC Code(s):
10702-017-01,
10702-017-04,
10702-017-06,
10702-017-24, view more10702-017-54
- Packager: KVK-Tech, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 19, 2018
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- Official Label (Printer Friendly)
- Chlorpheniramine maleate 12 mg
- USES
-
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 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
- DIRECTIONS
- OTHER INFORMATION
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INACTIVE INGREDIENTS
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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
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- PURPOSE
- Principal Display Panel - 24 Tablets Carton
- Principal Display panel - 60 Tablets Container Label
- PRINCIPAL DISPLAY PANEL
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Principal Display Panel - 4 Tablets in a sachet and a carton of 50 sachets
New Look. Same Trusted Ingredient. MADE IN USA
NDC 10702-017-04NDC 10702-017-54
Chlorphen-12
AllergySneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat3 in 1
Fast Acting
Long Lasting
Less Drowsy4 Tablets in a sachet and a carton of 50 sachets
Indoor & Outdoor Allergies
12-hour Extended-Release Tablets
Chlorpheniramine Maleate 12 mg/Antihistamine -
INGREDIENTS AND APPEARANCE
CHLORPHEN-12
chlorpheniramine maleate tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10702-017 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 12 mg Inactive Ingredients Ingredient Name Strength CALCIUM SULFATE (UNII: WAT0DDB505) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCROSE (UNII: C151H8M554) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) GELATIN (UNII: 2G86QN327L) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) METHYLPARABEN (UNII: A2I8C7HI9T) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color orange Score no score Shape ROUND Size 7mm Flavor Imprint Code Chlorphen;12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10702-017-06 60 in 1 BOTTLE; Type 0: Not a Combination Product 06/15/2010 2 NDC:10702-017-24 24 in 1 CARTON; Type 0: Not a Combination Product 06/15/2010 3 NDC:10702-017-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/15/2010 4 NDC:10702-017-54 50 in 1 CARTON 11/29/2018 4 NDC:10702-017-04 4 in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040829 06/15/2010 Labeler - KVK-Tech, Inc. (173360061) Registrant - Avanthi, Inc. (832316694) Establishment Name Address ID/FEI Business Operations KVK-Tech, Inc. 173360061 manufacture(10702-017)