DAYTIME NIGHTTIME COLD AND FLU RELIEF COMBO PACK- daytime nighttime cold and flu 
Allegiant Health

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438 - Daytime Nighttime Cold and Flu

Active ingredient(s)

DAYTIME ONLY

Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg

NIGHTTIME ONLY

Acetaminophen 325mg
Dextromethorphan HBr 15mg
Doxylamine succinate 6.25mg

Purpose

DAYTIME ONLY

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

 

NIGHTTIME ONLY

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Use(s)

DAYTIME ONLY

temporarily relieves common cold/flu symptoms: • nasal
congestion • cough due to minor throat & bronchial irritation • sore
throat • headache • minor aches & pains • fever

NIGHTTIME ONLY

temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation • sore throat • headache
• minor aches & pains • fever • runny nose & sneezing

Warnings

DAYTIME AND NIGHTTIME

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,
occurs with or is followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.

Do not use

DAYTIME ONLY

• 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.

NIGHTTIME ONLY

• 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

Ask a doctor before use if you have

DAYTIME ONLY

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

NIGHTTIME ONLY

• liver disease •glaucoma • 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 enlarged prostate gland

Ask a doctor or pharmacist before use if

DAYTIME ONLY

taking the blood thinning drug warfarin.

 

NIGHTTIME ONLY

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

DAYTIME ONLY

do not use more than directed

 

NIGHTTIME ONLY

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

Stop use and ask a doctor if

DAYTIME ONLY

• you get nervous, dizzy or sleepless
• symptoms get worse or last more than 5 days (children) or 7 days (adults)
• 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.

 

NIGHTTIME ONLY

• pain 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.

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

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

DAYTIME ONLY

adults and children 12 yrs & over: 2 softgels with water every 4 hrs

children 4 to under 12 yrs: ask a doctor

children under 4 yrs: do not use

 

NIGHTTIME ONLY

adults and children 12 yrs & over: 2 softgels with water every 6 hrs

children 4 to under 12 yrs: ask a doctor

children under 4 yrs: do not use


Other information

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

 

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

Questions

Questions or comments?
Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Principal Display Panel

Day Time/Nighttime Cold and Flu

Day Time/Nighttime Cold and Flu


DAYTIME NIGHTTIME COLD AND FLU RELIEF COMBO PACK 
daytime nighttime cold and flu kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-438
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-438-151 in 1 CARTON; Type 0: Not a Combination Product05/20/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 24 
Part 21 BLISTER PACK 12 
Part 1 of 2
DAYTIME COLD AND FLU 
acetaminophen 325mg/ dextromethorphan hbr 10mg/ phenylephrine hcl 5mg capsule
Product Information
Item Code (Source)NDC:69168-417
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:69168-417-932 in 1 CARTON
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/20/2022
Part 2 of 2
NIGHTTIME COLD AND FLU RELIEF 
acetaminophen capsule
Product Information
Item Code (Source)NDC:69168-418
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
ShapeCAPSULESize20mm
FlavorImprint Code PC10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-418-861 in 1 CARTON
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/20/2022
Labeler - Allegiant Health (079501930)

Revised: 5/2022
Document Id: d9eb6828-a31e-48c5-a6fd-f446f8845020
Set id: fa7ed5db-4da7-46b4-a08d-1d79cb7a5674
Version: 5
Effective Time: 20220519
 
Allegiant Health