Label: DAYTIME NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
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Contains inactivated NDC Code(s)
NDC Code(s): 70692-602-12 - Packager: Strive Pharmaceuticals 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 April 12, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients (in each Softgel) (Daytime) Purpose Acetaminophen 325mg Pain Reliever/fever reducer Dextromethorphan HBr 10mg Cough suppressant Phenylephrine HCl 5mg Nasal Decongestant Active ingredients (in each Softgel) (Nighttime) Purpose Acetaminophen 325mg Pain Reliever/fever reducer Dextromethorphan HBr 15mg Cough suppressant Docylamine Succinate 6.25mg Antihistamine - PURPOSE
- INDICATIONS & USAGE
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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 hrs, 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.
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).
Ask a doctor before use if you have
* liver disease
* heart disease (Daytime only)
* high blood pressure (Daytime only)
* thyroid disease (Daytime only)
* trouble urinating due to an enlarged prostate gland
* glaucoma (Nighttime only)
* persistent or chronic cough such as occurs with smoking, asthma or emphysema and (Nighttime only) chronic bronchitis
* cough that occurs with too much phlegm (mucus)Ask a doctor or a pharmacist before use if you are
* taking the blood thinning drug warfarin
* taking sedatives or tranquilizers (Nighttime only)
When using this product
Do not use more than directed. In addition when using Nighttime:
* excitability may occur, especially in children
* marked drowsiness may occur
* alcohol, sedatives, and tranquilizers may increase drowsiness
* be careful when driving a motor vehicle or operating machinery
* avoid alcoholic drinksStop use and ask a doctor if
* you get nervous, dizzy, or sleepless (Daytime only)
* pain, cough and nasal congestion (Daytime only) may get worse or lasts more than 7 days
* new symptoms occur
* fever gets worse or lasts more than 3 days
* redness or swelling is present
* cough comes back or occurs with rash or headache that lasts
These could be signs of a serious conditionIf pregnant or breast-feeding,
ask a health care professional before use.
Keep out of reach of childrenOVERDOSE WARNING:
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. - KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
* take only as directed - see OVERDOSE WARNING* do not exceed 4 doses per 24 hrs
* take softgels with waterRead each label carefully before taking Daytime and Nighttime product
Daytime Nighttime adulta & children age 12 years & over 2 softgels every 4 hours 2 softgels every 6 hours children 4 to under 12 years ask a doctor ask a doctor children under 4 years do not use do not use - OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients (Daytime)
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.
Inactive ingredients (Nightime)
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70692-602 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70692-602-12 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 11/06/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 8 Part 2 1 BLISTER PACK 4 Part 1 of 2 DAYTIME NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hbr , phenylephrine hcl capsule, liquid filledProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color red Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 604 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 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 11/06/2018 Part 2 of 2 DAYTIME NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filledProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color green Score no score Shape OVAL Size 19mm Flavor Imprint Code 603 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 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 11/06/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/06/2018 Labeler - Strive Pharmaceuticals Inc. (080028013)