Label: DAYTIME NON DROWSY COLD AND FLU AND NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
- NDC Code(s): 68210-5030-7
- Packager: Spirit Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 13, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients for Daytime (in each softgel) Acetaminophen 325 mgDextromethorphan HBr 10 mgPhenylephrine HCl 5 mg Active ingredients for Nigttime (in each softgel)Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg
- Purposes COLD & FLU NON DROWSY DAY RELIEFPain reliever/fever reducer Cough suppressant Nasal decongestant COLD & FLU NIGHT RELIEFPain reliever/fever reducer Cough suppressant Antihistamine
- Uses
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Warnings
Liver warningThis 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 productAllergy 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 warningIf 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
● to make a child sleepy (Nighttime only)
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Ask a doctor before use if you have
● cough that occurs with too much phlegm (mucus) ● liver disease
● trouble urinating due to enlarged prostate gland
● diabetes (Daytime only) ● heart disease (Daytime only)
● thyroid disease (Daytime only) ● high blood pressure (Daytime only)
● persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
● a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
● glaucoma (Nighttime only) - Ask a doctor or pharmacist before use if you are
- When using this product ● do not take more than directed ● marked drowsiness may occur (Nighttime only) ● avoid alcoholic drinks (Nighttime only) ● excitability may occur, especially in children (Nighttime only) ● be careful when driving a motor vehicle or operating machinery (Nighttime only) ● alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
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Stop use and ask a doctor if
● you get nervous, dizzy or sleepless (Daytime only)
● pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)
● pain or cough gets worse or lasts more than 7 days (Nighttime only)
● 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, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- Directions (Daytime only) ■ take only as directed - see Overdose warning ■ do not exceed 4 doses per 24 hours ■ adults and children 12 years and over: take 2 softgels with water every 4 hours ■ children 4 to under 12 years: ask a doctor ■ children under 4 years: do not use ■ when using other DAYTIME and NIGHTTIME products, carefully read each label to ensure correct dosingDirections (Nighttime only) ■ take only as directed - see Overdose warning ■ do not exceed 4 doses per 24 hours ■ adults and children 12 years and over: take 2 softgels with water every 6 hours ■ children 4 to under 12 years: ask a doctor ■ children under 4 years: do not use ■ when using other DAYTIME and NIGHTTIME products, carefully read each label to ensure correct dosing
- Other information
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Inactive ingredients
DAYTIME
FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, lecithin, myglyol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
NIGHTTIME
D&C Yellow# 10, FD&C Blue# 1, gelatin, glycerin, myglyol, lecithin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, polysorb, sorbitol sorbitan, titanium dioxide
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
DAYTIME NON DROWSY COLD AND FLU AND NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-5030 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-5030-7 1 in 1 CARTON; Type 0: Not a Combination Product 12/20/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 12 Part 2 1 BLISTER PACK 12 Part 1 of 2 DAYTIME NON DROWSY COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filledProduct Information Item Code (Source) NDC:68210-5031 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 5 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape OVAL Size 21mm Flavor Imprint Code 512;A09;AP01 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 in 1 CARTON 1 12 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 Drug M012 12/20/2023 Part 2 of 2 NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filledProduct Information Item Code (Source) NDC:68210-5032 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) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape OVAL Size 21mm Flavor Imprint Code 215;902;AP02 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 CARTON 1 12 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 Drug M012 12/20/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 12/20/2023 Labeler - Spirit Pharmaceuticals LLC (179621011)