Label: DAYTIME NIGHTTIME COLD/FLU RELIEF A P J- daytime nighttime cold/flu relief kit
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Contains inactivated NDC Code(s)
NDC Code(s): 46084-121-01, 46084-122-20, 46084-123-20 - Packager: A P J Laboratories Limited
- 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 May 20, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Keep out of reach of children
- USES
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WARNINGS
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take
•more than 4 doses in 24 hours, which is the maximum daily amount for these products
•with other drugs containing acetaminophen
•3 or more alcoholic drinks every day while using these products
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
Do not use
•with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
•if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
•to make a child sleep (Nighttime only)
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DIRECTIONS
•take only as directed – see Overdose warning
•take Nighttime OR Daytime.
Nighttime tablets
•do not exceed 4 doses per 24 hours
adults and children 12 years and over swallow 2 softgels with water every 6 hrs
children 4 to under 12 years ask a doctor
children under 4 years do not use
DayTime tablets
•do not exceed 4 doses per 24 hours
adults and children 12 years and over swallow 2 softgels with water every 4 hrs
children 4 to under 12 years ask a doctor
children under 4 years do not use
•when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME COLD/FLU RELIEF A P J
daytime nighttime cold/flu relief kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-121 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46084-121-01 1 in 1 PACKAGE Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 20 Part 2 1 BLISTER PACK 20 Part 1 of 2 DAYTIME COLD/FLU RELIEF A P J
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride tabletProduct Information Item Code (Source) NDC:46084-122 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) 30 mg STARCH, CORN (UNII: O8232NY3SJ) 12 mg BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .5 mg METHYLPARABEN (UNII: A2I8C7HI9T) .8 mg PROPYLPARABEN (UNII: Z8IX2SC1OH) .4 mg SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 8 mg TALC (UNII: 7SEV7J4R1U) 6 mg MAGNESIUM STEARATE (UNII: 70097M6I30) 6 mg SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 2 mg CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 3 mg SODIUM LAURYL SULFATE (UNII: 368GB5141J) 2 mg ISOPROPYL ALCOHOL (UNII: ND2M416302) 10 mg METHYLENE CHLORIDE (UNII: 588X2YUY0A) 20 mg FD&C YELLOW NO. 6 (UNII: H77VEI93A8) 2 mg HYPROMELLOSES (UNII: 3NXW29V3WO) 3 mg Product Characteristics Color pink (LIGHT YELLOWISH PINK) Score 2 pieces Shape OVAL (CAPSULE) Size 20mm Flavor Imprint Code 425mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46084-122-20 20 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/01/2013 Part 2 of 2 NIGHTTIME COLD/FLU RELIEF A P J
acetaminophen, dextromethorphan hydrobromide, chlorpheniramine maleate tabletProduct Information Item Code (Source) NDC:46084-123 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 6.25 mg Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) 30 mg STARCH, CORN (UNII: O8232NY3SJ) 12 mg BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .5 mg METHYLPARABEN (UNII: A2I8C7HI9T) .8 mg PROPYLPARABEN (UNII: Z8IX2SC1OH) .4 mg SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 8 mg TALC (UNII: 7SEV7J4R1U) 6 mg MAGNESIUM STEARATE (UNII: 70097M6I30) 6 mg SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 2 mg CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 3 mg SODIUM LAURYL SULFATE (UNII: 368GB5141J) 2 mg ISOPROPYL ALCOHOL (UNII: ND2M416302) 10 mg METHYLENE CHLORIDE (UNII: 588X2YUY0A) 20 mg FD&C YELLOW NO. 6 (UNII: H77VEI93A8) 2 mg HYPROMELLOSES (UNII: 3NXW29V3WO) 3 mg Product Characteristics Color white Score 2 pieces Shape OVAL (CAPSULE) Size 20mm Flavor Imprint Code 425mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46084-123-20 20 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/01/2013 Labeler - A P J Laboratories Limited (677378339) Registrant - A P J Laboratories Limited (677378339) Establishment Name Address ID/FEI Business Operations A P J Laboratories Limited 677378339 manufacture(46084-121)
