Label: ANTI ALLERGY- chlorpheniramine maleate tablet
- NDC Code(s): 17714-016-01, 17714-016-10
- Packager: Advance Pharmaceutical Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 30, 2017
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
-
Warnings
Ask a doctor before use if you have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
- you may get drowsy
- avoid alcoholic drinks
- alcohol, sedatives & tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating a machine
- excitability may occur, especially in children
If pregnant or breast-feeding, ask a health professional before use.
- Keep Out of Reach of Children
- Directions[/S]
- Other Information
- Inactive Ingredients
- Questions or Comments
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ANTI ALLERGY
chlorpheniramine maleate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17714-016 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color yellow (light yellow) Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code AP;016 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17714-016-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/09/2002 2 NDC:17714-016-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/09/2002 Labeler - Advance Pharmaceutical Inc. (078301063) Registrant - Advance Pharmaceutical Inc. (078301063) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical Inc. 078301063 manufacture(17714-016)