Label: DAYTIME NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
- NDC Code(s): 81179-044-01, 81179-088-01, 81179-803-01
- Packager: YET HEALTH GROUP LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 3, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- NIGHTTIME COLD & FLU Active ingredients (in each softgel)
- DAYTIME COLD & FLU Active ingredients (in each softgel)
- NIGHTTIME COLD & FLU Purpose
- DAYTIME COLD & FLU Purpose
- NIGHTTIME COLD & FLU Uses
- DAYTIME COLD & FLU Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- NIGHTTIME COLD & FLU Ask a doctor before use if you have
- DAYTIME COLD & FLU Ask a doctor before use if you have
- NIGHTTIME COLD & FLU Ask a doctor or pharmacist before use if you are
- DAYTIME COLD & FLU Ask a doctor or pharmacist before use if you are
- NIGHTTIME COLD & FLU When using this product
- DAYTIME COLD & FLU When using this product
- NIGHTTIME COLD & FLU Stop use and ask a doctor if
-
DAYTIME COLD & FLU
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
- If pregnant or breast-feeding,
- Keep out of reach of children.
- NIGHTTIME COLD & FLU Directions
- DAYTIME COLD & FLU Directions
- Other information
- NIGHTTIME COLD & FLU Inactive ingredients
- DAYTIME COLD & FLU Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME COLD AND FLU RELIEFÂ
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81179-803 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81179-803-01 1 in 1 CARTON 09/02/2021 1 1 in 1 BOTTLE; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 40 Part 2 1 BOTTLE 80 Part 1 of 2 NIGHTTIME COLD AND FLU RELIEFÂ
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filledProduct Information Item Code (Source) NDC:81179-044 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  POVIDONE (UNII: FZ989GH94E)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  GELATIN (UNII: 2G86QN327L)  GLYCERIN (UNII: PDC6A3C0OX)  SORBITOL (UNII: 506T60A25R)  POLYETHYLENE GLYCOL 1000000 (UNII: HZ58M6D839)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  SORBITAN (UNII: 6O92ICV9RU)  Product Characteristics Color green Score no score Shape OVAL Size 20mm Flavor Imprint Code IS2 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81179-044-01 40 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 09/02/2021 Part 2 of 2 DAYTIME COLD AND FLU RELIEFÂ
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filledProduct Information Item Code (Source) NDC:81179-088 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 SORBITOL (UNII: 506T60A25R)  WATER (UNII: 059QF0KO0R)  PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  FD&C RED NO. 40 (UNII: WZB9127XOA)  POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  GELATIN (UNII: 2G86QN327L)  GLYCERIN (UNII: PDC6A3C0OX)  POLYSORBATE 80 (UNII: 6OZP39ZG8H)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  SORBITAN (UNII: 6O92ICV9RU)  Product Characteristics Color red Score no score Shape OVAL Size 20mm Flavor Imprint Code IS1 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81179-088-01 80 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 09/02/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 09/02/2021 Labeler - YET HEALTH GROUP LLC (117763296) Establishment Name Address ID/FEI Business Operations Medgel Private Ltd 677385498 manufacture(81179-803)