DAYTIME AND NIGHTTIME COLD AND FLU KIT kit

Daytime and Nighttime Cold and Flu Kit by

Drug Labeling and Warnings

Daytime and Nighttime Cold and Flu Kit by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

DAYTIME ONLY

Acetaminophen 325mg

Dextromethorphan HBr 10mg

NIGHTTIME ONLY

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg

Purpose

DAYTIME ONLY

Pain reliever/fever reducer

Cough suppressant

NIGHTTIME ONLY

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Use(s)

DAYTIME ONLY

temporarily relieves these symptoms due to a cold or flu:

• cough
• sore throat
• headache
• minor aches and pains
• temporarily reduces 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

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

• more than 10 softgels in 24 hours, 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

NIGHTTIME

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
more than 4 doses in 24 hours, 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

DAYTIME AND NIGHTTIME

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 if you have

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.

• if you have ever had an allergic reaction to this product or any of its ingredients

• in children under 12 years of age

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

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 exceed recommended dosage.

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

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occurs
• pain, cough gets worse or last 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.

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.

If pregnant or 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

• Take only as directed

• Do not exceed 4 doses in 24hours

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

Children 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 24hours

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

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

Inactive ingredients

DAYTIME ONLY

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K12, 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/Comments

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Principal Display Panel

Daytime and Nighttime Cold and Flu

INGREDIENTS AND APPEARANCE

DAYTIME AND NIGHTTIME COLD AND FLU KIT 
daytime and nighttime cold and flu kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-013

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-013-15	1 in 1 CARTON; Type 0: Not a Combination Product	03/06/2026

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 BLISTER PACK	24
Part 2	1 BLISTER PACK	12

Part 1 of 2

DAYTIME COLD AND FLU 
daytime cold and flu capsule, liquid filled

Product Information
Item Code (Source)	NDC: 69168-474
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K12 (UNII: 333AG72FWJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	P41
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-474-93	2 in 1 CARTON
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/06/2026

Part 2 of 2

NIGHTTIME COLD AND FLU RELIEF 
acetaminophen capsule

Product Information
Item Code (Source)	NDC: 69168-418
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
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 (UNII: 506T60A25R)

Product Characteristics
Color	green (Clear)	Score	no score
Shape	CAPSULE (OBLONG)	Size	20mm
Flavor		Imprint Code	PC10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-418-86	1 in 1 CARTON
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/06/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/06/2026

Labeler - Allegiant Health (079501930)