Label: ALLERGY TIME- chlorpheniramine maleate tablet
- NDC Code(s): 49483-242-00, 49483-242-01, 49483-242-10, 49483-242-24
- Packager: Time Cap Labs Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 December 17, 2018
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR/PHARMACIST
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ALLERGY TIME
chlorpheniramine maleate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-242 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color yellow Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code TCL242 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-242-00 100000 in 1 CARTON; Type 0: Not a Combination Product 12/17/2018 2 NDC:49483-242-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/17/2018 3 NDC:49483-242-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/17/2018 4 NDC:49483-242-24 24 in 1 BLISTER PACK; Type 0: Not a Combination Product 12/17/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/08/2011 Labeler - Time Cap Labs Inc (037052099) Establishment Name Address ID/FEI Business Operations Time Cap Labs Inc 037052099 manufacture(49483-242)