DAYTIME NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl 
Strive Pharmaceuticals Inc.

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.

----------

DAYTIME NIGHTTIME COLD and FLU

Active ingredients (in each Softgel) (Daytime)Purpose
Acetaminophen 325mgPain Reliever/fever reducer
Dextromethorphan HBr 10mgCough suppressant
Phenylephrine HCl 5mgNasal Decongestant
Active ingredients (in each Softgel) (Nighttime)Purpose
Acetaminophen 325mgPain Reliever/fever reducer
Dextromethorphan HBr 15mgCough suppressant
Docylamine Succinate 6.25mgAntihistamine

Daytime

Pain reliever/fever reducer, Cough suppresant and Nasal decongestant

Nighttime

Pain reliever/fever reducer, Cough suppressant and Antihistamine

* temporarily relieves common cold/flu symptoms:

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 drinks

Stop 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 condition

If pregnant or breast-feeding,
ask a health care professional before use.

Keep out of reach of children

OVERDOSE 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
OVERDOSE 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.

Directions
* take only as directed - see OVERDOSE WARNING

* do not exceed 4 doses per 24 hrs
* take softgels with water

Read each label carefully before taking Daytime and Nighttime product

DaytimeNighttime
adulta & children age 12 years & over2 softgels every 4 hours2 softgels every 6 hours
children 4 to under 12 yearsask a doctorask a doctor
children under 4 yearsdo not usedo not use

Other information
* store at room temperature between 20 - 25°C (68 - 77°F)

*avoid excessive heat, cold and humidity

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.

Daytime Nighttime Cold & Flu

DAYTIME NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-602
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70692-602-121 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product11/06/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK
Part 21 BLISTER PACK
Part 1 of 2
DAYTIME NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr , phenylephrine hcl capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 604
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/06/2018
Part 2 of 2
DAYTIME NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorgreenScoreno score
ShapeOVALSize19mm
FlavorImprint Code 603
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/06/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/06/2018
Labeler - Strive Pharmaceuticals Inc. (080028013)

Revised: 4/2022
Document Id: dc792803-726f-f48d-e053-2a95a90a7369
Set id: 7a027fdf-a69a-9cbf-e053-2a91aa0ac4d6
Version: 3
Effective Time: 20220412
 
Strive Pharmaceuticals Inc.