Daytime Nighttime Cold and Flu Relief Combo Pack

Manufacturer
Allegiant Health
Effective date
2022-05-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:14:31

Label at a glance#

ProductDaytime Nighttime Cold and Flu Relief Combo Pack
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure9 sections

Dosage and administration

DAYTIME ONLY   Take only as directed  Do not exceed 4 doses in 24 hrs    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 Take only as directed  Do not exceed 4 doses in 24 hrs  adults and children 12 yrs & over:  2 softgels with water every 6 hrs children 4 to under 12 yrs:  ask a doctor children unde...

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

DAYTIME ONLY

Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg

NIGHTTIME ONLY

Acetaminophen 325mg
Dextromethorphan HBr 15mg
Doxylamine succinate 6.25mg

Purpose

OTC - PURPOSE SECTION

DAYTIME ONLY

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

 

NIGHTTIME ONLY

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Use(s)

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

DAYTIME ONLY

taking the blood thinning drug warfarin.

 

NIGHTTIME ONLY

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

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

DAYTIME ONLY

  •  Take only as directed
  •  Do not exceed 4 doses in 24 hrs   

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

  • Take only as directed
  •  Do not exceed 4 doses in 24 hrs 

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

SPL UNCLASSIFIED SECTION

  • store at room temperature 20-25 °C (68-77° F)
  • do not use if blister unit is torn or open

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Daytime and Nighttime
Daytime and Nighttime

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2634564{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } PackGPCK6
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSN6
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN6
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN6
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD6
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD6
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSY6
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY6
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-417-93Daytime Nighttime Cold and Flu Relief Combo Pack12 in 1 BLISTER PACKCAPSULE245 mg6
69168-417-93Daytime Nighttime Cold and Flu Relief Combo Pack2 in 1 CARTONCAPSULE5 mg6
69168-418-86Daytime Nighttime Cold and Flu Relief Combo Pack12 in 1 BLISTER PACKCAPSULE12325 mg6
69168-418-86Daytime Nighttime Cold and Flu Relief Combo Pack1 in 1 CARTONCAPSULE6.25 mg6
69168-438-15Daytime Nighttime Cold and Flu Relief Combo Pack1 in 1 CARTONKIT16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-43869168-438-15
69168-41769168-417-93
69168-41869168-418-86

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime and Nighttime Cold and Flu KitDAYTIME AND NIGHTTIME COLD AND FLU KITAllegiant Health0533db78-7809-46ea-9998-deb5f6f1d0d92026-03-06WarningsExact identifier
ndc (package): 69168-418-86
ndc11 (package): 69168041886
Daytime Nighttime Cold and Flu Relief Combo PackDAYTIME NIGHTTIME COLD AND FLUAllegiant Healthfa7ed5db-4da7-46b4-a08d-1d79cb7a56742022-05-19WarningsExact identifier
ndc (package): 69168-418-86
ndc (package): 69168-438-15
ndc (package): 69168-417-93
ndc (product): 69168-438
ndc11 (package): 69168041886
ndc11 (package): 69168043815
ndc11 (package): 69168041793
spl id: e50f1230-f2bc-4bf1-8488-c1d8525e368c
spl set id: fa7ed5db-4da7-46b4-a08d-1d79cb7a5674
Daytime Cold and FluACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MGAllegiant Healthbed5f9dc-45ea-4e90-86c6-86599b6f38612020-11-16WarningsExact identifier
ndc (product): 69168-417
Nighttime Cold and Flu ReliefACETAMINOPHENAllegiant Healthb97126d7-847d-483e-b3d1-e2b61ab1743f2020-11-11WarningsExact identifier
ndc (product): 69168-418

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.