DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF- day and night multi symptom cold and flu relief 
Intrivo Diagnostics Inc.

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Day and Night Multi Symptom Cold and Flu Relief

Active ingredient(s)

Active Ingredients (in each softgel)
Nighttime only
Acetaminophen 325mg
Dextromethorphan HBr 15mg
Doxylamine succinate 6.25mg

Active Ingredients (in each softgel)
Daytime only
Acetaminophen 325mg
Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purpose

Nighttime only
Pain reliever/fever reducer
Cough suppressant
Antihistamine

Daytime only
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Use(s)

temporarily relieves common cold and flu symptoms:

Warnings


Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take

Allergy alert: Acetaminophen may cause severe skin
reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right
away.

Sore throat warning: If sore throat is severe, lasts for more
than 2 days, occurs with or followed by fever, headache, rash,
nausea, or vomiting, see 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 drugs. 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

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to an enlarged prostate gland
  • glaucoma (Nighttime only)
  • heart disease
  • thyroid disease
  • diabetes high blood sugar (Daytime only)

Ask a doctor or pharmacist before use if

you are taking the blood thinning drug warfarin

  •  taking sedatives or tranquilizers (Nighttime only)

When using this product

When using this product

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drink
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • pain 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.
  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults) (Daytime only)
    These could be signs of a serious condition.

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center

(1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

Directions (Nighttime only)

Directions (Daytime only)

Other information

Inactive ingredients

Inactive ingredients (Nighttime only)

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, sorbitol sorbitan
solution, white edible ink

Inactive ingredients (Daytime only)

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone,
propylene glycol, purified water, sorbitol sorbitan solution, white
edible ink

Questions/Comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Principal Display Panel

Daytime and Nighttime softgels

Daytime and Nighttime softgels

DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF 
day and night multi symptom cold and flu relief kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83558-020
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83558-020-022 in 1 CARTON10/28/2023
11 in 1 CARTON; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 10 
Part 21 BLISTER PACK 10 
Part 1 of 2
DAYTIME COLD AND FLU RELIEF 
daytime cold and flu relief capsule, liquid filled
Product Information
Item Code (Source)NDC:83558-021
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code PC9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83558-021-011 in 1 CARTON
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/28/2023
Part 2 of 2
NIGHTTIME COLD AND FLU RELIEF 
nighttime cold and flu relief capsule, liquid filled
Product Information
Item Code (Source)NDC:83558-022
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code PC10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/28/2023
Labeler - Intrivo Diagnostics Inc. (118833259)

Revised: 10/2023
Document Id: 6c999083-433a-481f-9ae4-cd0ca9e12e86
Set id: a311bf39-de6c-4ed5-949e-718ad8be1e49
Version: 2
Effective Time: 20231013
 
Intrivo Diagnostics Inc.