Label: DAY-TIME NIGHT-TIME- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-490-40 - Packager: Chain Drug Consortium, LLC
- 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 October 26, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients for Night-Time (in each softgel)
- Active ingredients for Day-Time (in each softgel)
- Purpose for Nighttime
- Purpose for Daytime
- Uses
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Warnings
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take
- more than 6 doses in 24 hours (Night-Time), which is the maximum daily amount
- more than 6 doses in 24 hours (Day-Time), which is the maximum daily amount
- 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, rash, nausea, or vomiting, consult a doctor promptly.
Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms
Do not use
- with other drugs 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
Ask a doctor before using if you have
- liver disease
- heart disease
- asthma
- emphysema
- thyroid disease
- diabetes
- high blood pressure
- cough with excessive phlegm (mucus)
- breathing problems
- chronic bronchitis
- persistent or chronic cough
- cough associated with smoking
- trouble urinating due to enlarged prostate gland
- glaucoma (Night-Time only)
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not use more than directed, in addition when using Night-Time:
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives and tranquilizers may increase drowsiness
- do not use with other products containing acetaminophen
Stop use and ask a doctor if
- swelling or redness is present
- symptoms do not get better within 7 days or are accompanied by a fever
- you get nervous, dizzy or sleepless
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache. These may be signs of a serious condition.
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Directions
- take only as recommended (see overdose warning)
- take Night-Time or Day-Time
age Night-Time Day-Time adults and children 12 years of age and older swallow 2 softgels with water every 6 hours swallow 2 softgels with water every 4 hours children 4 to 12 years of age ask a doctor ask a doctor children under 4 years of age do not use do not use - If taking Night-Time and Day-Time softgels limit total to 4 doses per day
- Other information
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Inactive ingredients
Night-Time D&C Yellow #10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol 400 NF, *polyethylene glycol (PEG)- 600, povidone, propylene glycol USP, purified water USP, sorbitan, sorbitol and white edible ink. *May also contain
Day-Time *butylated hydroxyanisole, *butylated hydroxytoluene, *carmine, *D&C yellow #10, FD&C Red#40, FD&C yellow #6, gelatin, glycerin USP, *mannitol, polyethylene glycol 400 NF, *polyethylene glycol 600, povidone, propylene glycol USP, purified water USP, *sodium metabisulfite, *sorbitan, *sorbitol, sorbitol special, and white edible ink. *May also contain.
- Questions or comments?
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Principal Display Panel
*Compare to active ingredients in Vicks® Dayquil® & Nyquil®
SEE NEW WARNINGS INFORMATION
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
DISTRIBUTED BY:
CHAIN DRUG CONSORTIUM, LLC.
2300 NW CORPORATE BLVD., SUITE 115
BOCA RATON, FL 33431
- Product Label
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INGREDIENTS AND APPEARANCE
DAY-TIME NIGHT-TIME
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-490 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-490-40 1 in 1 CARTON; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 BLISTER PACK 20 Part 2 2 BLISTER PACK 20 Part 1 of 2 NIGHT-TIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsuleProduct Information 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 DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) POVIDONES (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color GREEN Score no score Shape CAPSULE Size 20mm Flavor Imprint Code P30;94A;35A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 Part 2 of 2 DAY-TIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsuleProduct Information 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) MANNITOL (UNII: 3OWL53L36A) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) POVIDONES (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color ORANGE (red) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code P19;95A;36A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/12/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/12/2010 Labeler - Chain Drug Consortium, LLC (101668460)
