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

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Day and Night Cold Symptom Relief

Active ingredient(s)

Active ingredient (in each caplet) (Nighttime only)

Acetaminophen 325mg
Chlorpheniramine maleate 2mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg

Active Ingredients (in each caplet) (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)

for the temporary relief of the following cold/flu symptoms

  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion 
  • cough
  • sinus congestion and pressure 
  • temporarily reduces fever
  • sneezing and runny nose
  • helps clear nasal passages
  • relieves cough to help you sleep (Nighttime only)
  •  helps loosen phlegm (mucus) and thin bronchial secretions to make coughs
    more productive (Daytime only)

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. (Nighttime only)

Severe liver damage may occur if you take:

  • more than 12 caplets in 24 hours, which is the maximum daily amount (Daytime only)

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, occurs with or is 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.
  • if you have ever had an allergic reaction to this product or any of its
    ingredients (Nighttime only)

Ask a doctor before use if

you have have

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

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery (Nighttime only)

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • 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 breastfeeding,

ask a health professional before use. 

Keep out of reach of children

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).
Quick medical attention is critical for adults as well as for children even if you
do not notice any signs or symptoms. Taking more than the recommended dose
(overdose) may cause liver damage.

Directions

Directions (Nighttime only)

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and older: take 2 caplets every 4 hours
  • swallow whole; do not crush, chew or dissolve
  • do not take more than 10 caplets in 24 hours
  • Children under 12 years: ask a doctor

Directions (Daytime only)

  • do not take more than directed (see Warnings)
  • Adults and children 12 years and over: take 2 caplets every 4 hours
  • do not take more than 12 caplets in 24 hours
  • Children under 12 years: do not use this adult product in children under 12 years of age.

This will provide more than the recommended dose (overdose) and
may cause liver damage

Other information

  • store at room temperature 20°– 25°C (68°– 77°F
  • do not use if blister unit is torn or open
  • Retain carton for complete drug information.

Inactive ingredients

Inactive ingredients (Nighttime only)

corn starch, crospovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose,
magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch,
polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide
May contain: FD&C lake black

Inactive ingredients (Daytime only)

colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, hydroxypropyl methylcellulose,
magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone,
pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Questions/Comments

Questions or comments?
Call 1-888-952-0050 Monday through Friday

Principal Display Panel

Daytime and Nighttime Cold and Flu

Daytime and Nighttime Cold and Flu

DAY AND NIGHT COLD SYMPTOM RELIEF 
day and night cold symptom relief kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83558-017
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83558-017-011 in 1 CARTON; Type 0: Not a Combination Product07/31/202302/29/2024
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 10 BLISTER PACK
Part 21 BLISTER PACK 12 
Part 1 of 2
NIGHTTIME COLD AND FLU RELIEF 
nighttime cold and flu relief capsule
Product Information
Item Code (Source)NDC:83558-019
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 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
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 2S7830E561)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code AZ319
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83558-019-0112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/31/202302/29/2024
Part 2 of 2
DAYTIME COLD AND FLU RELIEF 
daytime cold and flu relief capsule
Product Information
Item Code (Source)NDC:83558-018
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code AZ324
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83558-018-0112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/31/202302/29/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/31/202302/29/2024
Labeler - Intrivo Diagnostics Inc. (118833259)

Revised: 7/2023
 
Intrivo Diagnostics Inc.